Nix Shampoo — FDA prescribing information, side effects and uses

Nix Shampoo

Generic Name: permethrin
Dosage Form: shampoo

Medically reviewed by Drugs.com. Last updated on May 22, 2019.

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Active ingredient (in each fluid ounce) Purpose

Permethrin 280 mg (1%). Lice treatment

treats head lice

Warnings

For external use only

  • on children under 2 months of age
  • near the eyes
  • inside the nose, ear, mouth, or vagina
  • on lice in eyebrows or eyelashes. See your doctor.

Ask a doctor before use if you are

  • allergic to ragweed. May cause breathing difficulty or an asthmatic episode.

When using this product

  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets into the eyes, immediately flush with large amounts of water
  • scalp itching or redness may occur

Stop use and see a doctor if

  • breathing difficulty occurs
  • eye irritation occurs
  • skin or scalp irritation continues or infection occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • all household members should be checked by another person for lice and/or nits (eggs)
  • use a magnifying glass in bright light to help you see the lice and nits (eggs)
  • use a tool, such as a comb or two unsharpened pencils to lift and part the hair
  • look for tiny nits near the scalp, beginning at the back of the neck and behind the ears
  • small sections of hair (1-2 inches wide) should be examined at a time
  • unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.
  • if either lice or nits (eggs) are found, treat with Nix Creme Rinse
  • wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Nix. Rinse with water.
  • towel dry hair so it is damp but not wet
  • shake the bottle of Nix well
  • completely saturate the hair and scalp with Nix. Begin to apply Nix behind the ears and at the back of the neck.
  • keep Nix out of the eyes. Protect the eyes with a washcloth or towel.
  • leave Nix on the hair for 10 minutes, but no longer
  • rinse with warm water
  • towel dry hair and comb out tangles
  • if live lice are seen seven days or more after the first treatment, a second treatment should be given
  • remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out.
  • use the nit comb provided and make sure the hair remains slightly damp while removing nits
  • if the hair dries during combing, dampen it slightly with water
  • part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours).
  • start at the top of the head on the section you have picked
  • with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair.
  • use clips to pin back each strand of hair after you have combed out the nits
  • clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back.
  • after combing, recheck the entire head for nits and repeat combing if necessary
  • check the affected head daily to remove any nits that you might have missed

Other information

  • read all the directions in the Consumer Information Insert and warnings before use. Keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

balsam canada, cetyl alcohol, citric acid, FD&C yellow no. 6, fragrance, hydrolyzed animal protein, hydroxyethylcellulose, polyoxyethylene 10 cetyl ether, propylene glycol, stearalkonium chloride, water, isopropyl alcohol 5.6 g (20%), methylparaben 56 mg (0.2%), and propylparaben 22 mg (0.08%)

Questions or comments?

call 1-888-LICE LINE (1-888-542-3546), Monday to Friday, 9 AM — 5 PM EST

LIMITED CONSUMER WARRANTY
If you are not satisfied with Nix, we will refund your purchase price. Send cash register receipt, original UPC code, and reason for dissatisfaction to:
INSIGHT Pharmaceuticals Corp.
1170 Wheeler Way, Suite 150
Langhorne, PA 19047-1749

Distributed by:
INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

For a description of all of our products visit us at www.insightpharma.com

Nix ®
Permethrin 1%
Lice Treatment Creme Rinse

THE FACTS OF LICE

Please read all information before using Nix Creme Rinse.

If you or a member of your household has head lice, don’t panic. Keep calm.

Anyone can get head lice — it has nothing to do with cleanliness or poor hygiene. Head lice are treatable and very rarely cause serious health problems.

What are head lice?

  • head lice are small insects that live and feed on the human scalp
  • they may get as big as sesame seeds and are brown
  • lice do not fly or jump from one person to another. They can only crawl.
  • nits are lice eggs laid on the hair near the scalp. One louse may lay over 100 nits.
  • nits are oval shaped, tiny and greyish-white
  • they are attached to hair with a waterproof glue-like substance that cannot be washed out or blown away

Because nits (eggs) hatch in about one week, all nits must be removed to stop lice.

See also:  What Do I Do About Rats Under My House? Pest Control Products

How do head lice spread?

  • head lice spread easily from close head-to-head or hand-to-head contact with persons who have lice
  • they may also spread by sharing hats, helmets, scarves, headphones, brushes, combs, bedding and clothing

How do you know if you have lice?

  • itching is the most common symptom
  • scratching behind the ears or the back of the neck is a sign that you should check for head lice
  • scabs or blood spots may be seen

How do you prevent the spread of lice?

  • do not share or borrow personal items like combs, brushes, or headbands
  • do not share or borrow hats, sweaters, coats, scarves, helmets, headphones, pillows or stuffed animals
  • store hats in coat sleeves and hang coats separately, so that they do not touch other people’s hats and coats
  • wash under fingernails when you first see lice or nits (eggs)
  • check your child’s head daily when you hear of a lice outbreak in day care or school

If you suspect head lice — check. Head lice may be hard to locate because they avoid light. Nits are easier to see.

  • all household members should be checked by another person for lice and/or nits (eggs)
  • use a magnifying glass in bright light to help you see the lice and nits (eggs)
  • use a tool, such as a comb or two unsharpened pencils to lift and part the hair
  • look for tiny nits near the scalp, beginning at the back of the neck and behind the ears
  • small sections of hair (1-2 inches wide) should be examined at a time
  • unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.
  • if either lice or nits (eggs) are found, treat with Nix Creme Rinse
  • wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Nix. Rinse with water.
  • towel dry hair so it is damp but not wet
  • shake the bottle of Nix well
  • completely saturate the hair and scalp with Nix. Begin to apply Nix behind the ears and at the back of the neck.
  • keep Nix out of the eyes. Protect the eyes with a washcloth or towel.
  • leave Nix on the hair for 10 minutes, but no longer
  • rinse with warm water
  • towel dry hair and comb out tangles
  • if live lice are seen seven days or more after the first treatment, a second treatment should be given

III. Remove Lice/Nits

Treatment kills lice but does not remove the nits.

  • remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out.
  • use the nit comb provided and make sure the hair remains slightly damp while removing nits
  • if the hair dries during combing, dampen it slightly with water
  • part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours).
  • start at the top of the head on the section you have picked
  • with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair.
  • use clips to pin back each strand of hair after you have combed out the nits
  • clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back.
  • after combing, recheck the entire head for nits and repeat combing if necessary
  • check the affected head daily to remove any nits that you might have missed

IV. Clean home and personal items

After using Nix Creme Rinse, it is very important to clean personal items and your home to prevent the spread of lice. Nits may live away from the human head for about 7-12 days. Lice may live away from the human head for about 1 day.

  • all personal head gear (hats, hair ribbons, etc.), scarves, coats, towels and bed linens should be washed in hot water (above 130°F), then dried in the dryer using the hottest cycle for at least 20 minutes
  • personal combs, including nit combs, and brushes should be soaked in hot water (above 130°F) for at least 10 minutes
  • personal articles such as clothing, bedspreads, blankets, pillows or stuffed animals that cannot be washed should be dry-cleaned or sealed tightly in a plastic bag for a period of at least 4 weeks. Items should be taken out of the plastic bag outdoors and shaken out very hard before using again.
  • for anything you cannot wash, dry-clean or store in a plastic bag, spray with Nix Lice Control Spray.
  • vacuum everywhere. Vacuum all carpets, mattresses, upholstered furniture and car seats that may have been used by infested household members.

For external use only

  • on children under 2 months of age
  • near the eyes
  • inside the nose, ear, mouth, or vagina
  • on lice in eyebrows or eyelashes. See your doctor.

Ask a doctor before use if you are

  • allergic to ragweed. May cause breathing difficulty or an asthmatic episode.

When using this product

  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets into the eyes, immediately flush with large amounts of water
  • scalp itching or redness may occur

Stop use and see a doctor if

  • breathing difficulty occurs
  • eye irritation occurs
  • skin or scalp irritation continues or infection occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions or comments?
call 1-888-LICE LINE (1-888-542-3546),
Monday to Friday, 9 AM — 5 PM EST

Distributed by:
INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19049-1749

PRINCIPAL DISPLAY PANEL — 2 oz Carton

SAFE
Approved for use on children
over 2 months of age

Nix ®
Permethrin
LICE TREATMENT

PROFESSIONALLY
#1
RECOMMENDED

With A Single Application

  • Kills Lice & Their Eggs

Prevents Reinfestation for 14 Days

  • Full Prescription Strength

Creme Rinse and Nit Removal Comb

See also:  COVID-19: Prevention - Investigational Treatments

Instrucciones En Español Incluidas

PRINCIPAL DISPLAY PANEL — 4 oz Carton

SAFE
Approved for use on children
over 2 months of age

Nix ®
Permethrin
LICE TREATMENT

PROFESSIONALLY
#1
RECOMMENDED

With A Single Application

  • Kills Lice & Their Eggs

Prevents Reinfestation for 14 Days

  • Full Prescription Strength

2 Bottles Creme Rinse and 2 Nit Removal Combs

Instrucciones En Español Incluidas

2 BOTTLES
2 FL OZ (59 mL) EACH
FAMILY PACK

www.drugs.com

Permethrin

Medically reviewed by Drugs.com. Last updated on Apr 1, 2019.

On This Page

DESCRIPTION

Permethrin Cream, 5% is a topical scabicidal agent for the treatment of infestation with Sarcoptes scabiei (scabies). It is available in an off-white, vanishing cream base. Permethrin Cream, 5% is for topical use only.

Chemical Name – The Permethrin used is an approximate 1:3 mixture of the cis and trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylic acid, (3-phenoxyphenyl) methyl ester. Permethrin has a molecular formula of C 21 H 20 Cl 2 O 3 and a molecular weight of 391.29. It is a yellow to light orange-brown, low melting solid or viscous liquid.

Active Ingredient – Each gram contains Permethrin 50 mg (5%).

Inactive Ingredients – Butylated hydroxytoluene, carbomer homopolymer type B, fractionated coconut oil, glycerin, glyceryl monostearate, isopropyl myristate, lanolin alcohols, mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative.

CLINICAL PHARMACOLOGY

Permethrin, a pyrethroid, is active against a broad range of pests including lice, ticks, fleas, mites, and other arthropods. It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization and paralysis of the pests are the consequences of this disturbance.

Permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. Although the amount of Permethrin absorbed after a single application of the 5% cream has not been determined precisely, data from studies with 14 C-labeled Permethrin and absorption studies of the cream applied to patients with moderate to severe scabies indicate it is 2% or less of the amount applied.

INDICATIONS AND USAGE

Permethrin Cream, 5% is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).

CONTRAINDICATIONS

Permethrin Cream, 5% is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.

WARNINGS

If hypersensitivity to Permethrin Cream, 5% occurs, discontinue use.

PRECAUTIONS

General

Scabies infestation is often accompanied by pruritus, edema, and erythema. Treatment with Permethrin Cream, 5% may temporarily exacerbate these conditions.

Information for Patients

Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of Permethrin Cream, 5%. In clinical trials, approximately 75% of patients treated with Permethrin cream, 5% who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician. Permethrin Cream, 5% may be very mildly irritating to the eyes. Patients should be advised to avoid contact with eyes during application and to flush with water immediately if Permethrin Cream, 5% gets in the eyes.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Six carcinogenicity bioassays were evaluated with Permethrin, three each in rats and mice. No tumorigenicity was seen in the rat studies. However, species-specific increases in pulmonary adenomas, a common benign tumor of mice of high spontaneous background incidence, were seen in the three mouse studies. In one of these studies there was an increased incidence of pulmonary alveolar-cell carcinomas and benign liver adenomas only in female mice when Permethrin was given in their food at a concentration of 5000 ppm. Mutagenicity assays, which give useful correlative data for interpreting results from carcinogenicity bioassays in rodents, were negative. Permethrin showed no evidence of mutagenic potential in a battery of in vitro and in vivo genetic toxicity studies.

Permethrin did not have any adverse effect on reproductive function at a dose of 180mg/kg/day orally in a three-generation rat study.

Pregnancy: Teratogenic Effects: Pregnancy Category B

Reproduction studies have been performed in mice, rats, and rabbits (200 to 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to Permethrin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the evidence for tumorigenic potential of Permethrin in animal studies, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing.

Pediatric Use

Permethrin Cream, 5% is safe and effective in pediatric patients two months of age and older. Safety and effectiveness in infants less than two months of age have not been established.

Geriatric Use

Clinical studies of Permethrin cream, 5% did not identify sufficient numbers of subjects aged 65 and over to allow a definitive statement regarding whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney. However, since topical Permethrin is metabolized in the liver and excreted in the urine as inactive metabolites, there does not appear to be an increased risk of toxic reactions in patients with impaired renal function when used as labeled.

Adverse Reactions

In clinical trials, generally mild and transient burning and stinging followed application with Permethrin cream, 5% in 10% of patients and was associated with the severity of infestation. Pruritus was reported in 7% of patients at various times post-application. Erythema, numbness, tingling, and rash were reported in 1 to 2% or less of patients (See PRECAUTIONS-General ). Other adverse events reported since marketing Permethrin cream, 5% include: headache, fever, dizziness, abdominal pain, diarrhea and nausea and/or vomiting. Although extremely uncommon and not expected when used as directed (see DOAGE AND ADMINISTRATION ), rare occurrences of seizure have been reported. None have been medically confirmed as associated with Permethrin Cream, 5% treatment.

OVERDOSAGE

No instance of accidental ingestion of Permethrin Cream, 5% has been reported. If ingested, gastric lavage and general supportive measures should be employed. Excessive topical use (see DOSAGE AND ADMINISTRATION ) may result in increased irritation and erythema.

See also:  Fleas on Humans: Pulex Bites, Symptoms, Prevention - Treatment Tips

DOSAGE AND ADMINISTRATION

Adults and Children

Thoroughly massage Permethrin Cream, 5% into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients. Usually 30 grams is sufficient for an average adult. The cream should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple, and forehead. ONE APPLICATION IS GENERALLY CURATIVE.

Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for retreatment. Demonstrable living mites after 14 days indicate that retreatment is necessary.

HOW SUPPLIED

Permethrin Cream, 5% (w/w) is available as follows:

60 g tube (NDC 16714- 897 -01)

STORAGE

Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Manufactured for: Northstar Rx LLC Memphis, TN 38141.

Manufactured by: Perrigo, Bronx, NY 10457.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Permethrin Cream, 5%*

For External Use Only. Not for Use In Eyes.

www.drugs.com

Permethrin Topical

Why is this medication prescribed?

Permethrin is used to treat scabies (‘mites that attach themselves to the skin) in adults and children 2 months of age and older. Over-the-counter permethrin is used to treat lice (small insects that attach themselves to the skin on the head) in adults and children 2 months of age and older. Permethrin is in a class of medications called scabicides and pediculicides. It works by killing lice and mites.

How should this medicine be used?

Permethrin comes as a cream to apply to the skin. Over-the-counter permethrin comes as a lotion to apply to the scalp and hair. Permethrin cream is usually applied to the skin in one treatment, but occasionally a second treatment is necessary. Permethrin lotion is usually applied to the skin in one or two treatments, but occasionally three treatments are necessary. If live mites are seen two weeks (14 days) after the first treatment with permethrin cream, then a second treatment should be applied. If live lice are seen one week after the first treatment with over-the-counter permethrin lotion, then a second treatment should be applied. Follow the directions on your prescription label or the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use permethrin exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Permethrin should only be used on the skin or hair and scalp. Avoid getting permethrin in your eyes, nose, ears, mouth, or vagina. Do not use permethrin on your eyebrows or eyelashes.

If permethrin gets in your eyes, flush them with water right away. If your eyes are still irritated after flushing with water, call your doctor or get medical help right away.

To use permethrin cream, follow these steps:

  1. Apply a thin layer of cream all over your skin from your neck down to your toes (including the soles of your feet). Be careful to apply cream in all skins folds, such as between your toes and fingers or around your waist or buttocks.
  2. For treatment of babies or adults over 65 years of age, the cream should also be applied to the scalp or hairline, temples, and forehead.
  3. You may need to use all of the cream in the tube to cover your body.
  4. Leave the cream on your skin for 8-14 hours.
  5. After 8-14 hours have passed, wash off the cream by bathing or showering.
  6. Your skin may be itchy after treatment with permethrin cream. This does not mean your treatment did not work. If you see live mites 14 days or more after treatment, then you will need to repeat the treatment process.

To use the lotion, follow these steps:

  1. Wash your hair with shampoo and rinse with water. Do not use a conditioner or a shampoo that contains a conditioner because your treatment will not work as well.
  2. Dry your hair with a towel until just damp.
  3. Shake permethrin lotion well right before use to mix the medication evenly.
  4. Use a towel to cover your face and eyes. Be sure to keep your eyes closed during this treatment. You may need to have an adult help you apply the lotion.
  5. Apply permethrin lotion to your hair and scalp area. Begin to apply the lotion behind your ears and at the back of your neck and then cover all of the hair on your head and scalp.
  6. Keep the lotion on your hair and scalp for 10 minutes after you finish applying permethrin lotion. You should use a timer or clock to track the time.
  7. Rinse your hair and scalp with warm water in a sink. You should not use a shower or bathtub to rinse the lotion away because you do not want to get the lotion over the rest of your body.
  8. Dry your hair with a towel and comb out tangles.
  9. You and anyone who helped you apply the lotion should wash your hands carefully after the application and rinsing steps.
  10. A lice comb may also be used to remove the dead lice and nits (empty egg shells) after this treatment. You may also need to have an adult help you to do this.
  11. If you see live lice on your head 7 days or more after treatment, repeat this entire process.

After using permethrin, sanitize all the clothing, underwear, pajamas, hats, sheets, pillowcases, and towels you have used recently. These items should be washed in very hot water or dry-cleaned. You should also wash combs, brushes, hairs clips and other personal care items in hot water.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

medlineplus.gov

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