Your browser does not support JavaScript! NIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (PERMETHRIN) KIT [INSIGHT PHARMACEUTICALS]
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NIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION (permethrin) kit
[Insight Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

Creme Rinse

Drug Facts

Active ingredient (in each fluid ounce)

Permethrin 280 mg (1%)

Purpose

Lice treatment

Uses

treats head lice

Warnings

For external use only

Do not use

  • 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 ask 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

Important: Read warnings before use:

  • Adults and children 2 months old and older

Inspect

  • check each household member with a magnifying glass in bright light for lice/nits (eggs)
  • look for tiny nits near scalp, beginning at back of neck and behind ears
  • examine small sections of hair at a time
  • unlike dandruff which moves when touched, nits stick to the hair
  • if either lice or nits are found, treat with Nix Creme Rinse

Treat

  • 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 Lice/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

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

canada balsam, cetyl alcohol, citric acid anhydrous, FD&C yellow no. 6, fragrance, hydrolyzed animal protein, hydroxyethyl cellulose, polyoxyethylene 10 cetyl ether, propylene glycol, stearalkonium chloride, water, isopropyl alcohol, methylparaben, propylparaben

Combing Gel

For external use only. Avoid contact with the eyes.

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

Directions

  • Use after shampooing with lice killing Nix creme rinse. When you finish combing, rinse hair thoroughly with warm water. Nix Combing Gel does not kill lice and nits. Read all the directions in the Consumer Information Insert before use.

Ingredients

purified water, propylene glycol, glycerin, polyquaternium-10, diazolidinylurea, hydroxyethyl cellulose, sodium citrate dihydrate, citric acid, methylparaben, propylparaben, disodium EDTA

Distributed by Insight Pharmaceuticals Corp. 900 Northbrook Drive, Suite 200 Trevose, PA 19053-8433

Nix®
PERMETHRIN

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.

What are nits?

  • 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.

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

How to use NIX® Creme Rinse?

Inspect

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

Figure
  • check each household member with a magnifying glass in bright light for lice/nits (eggs)
  • look for tiny nits near scalp, beginning at back of neck and behind ears
  • examine small sections of hair at a time
  • unlike dandruff which moves when touched, nits stick to the hair
  • if either lice or nits are found, treat with Nix Creme Rinse
Treat
  • 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
Figure
  • 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 Lice/Nits
Treatment kills lice but does not remove the nits.

  • remove nits by combing the hair with the premium comb provided. Remaining nits may be removed by hand (using a throw- away glove), or cutting the nits out.
Figure
  • 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

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.

Figure
  • 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, use a lice control spray.
  • vacuum everywhere. Vacuum all carpets, mattresses, upholstered furniture and car seats that may have been used by infested household members.
Figure

Warnings

For external use only

Do not use

  • 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

www.nixlice.com

Distributed by:
INSIGHT Pharmaceuticals, LLC.
Trevose, PA 19053-8433

61-16-360B
© 2013

PRINCIPAL DISPLAY PANEL - Kit Carton

Nix®
PERMETHRIN

Have questions?
Call our expert hotline
888.542.3546

PEDIATRICIAN RECOMMENDED
#1
TREATMENT

Safe for use on children over 2 months old

COMPLETE Maximum Strength
Lice Elimination Kit

BONUS!
LICE CONTROL
SPRAY INCLUDED

Includes
Exclusive Lice
Removal &
Hair Detangler
Comb

Creme Rinse 2 Bottles 2 fl oz (59 mL) EACH,
Combing Gel 2 fl oz (59 mL), Lice Comb

nixlice.com

Principal Display Panel - Kit Carton
NIX COMPLETE MAXIMUM STRENGTH LICE ELIMINATION 
permethrin kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63736-027
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-027-061 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BOTTLE 118 mL
Part 21 BOTTLE 59 mL
Part 1 of 2
NIX 
permethrin shampoo
Product Information
Item Code (Source)NDC:63736-024
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Permethrin (Permethrin) Permethrin560 mg  in 59 mL
Inactive Ingredients
Ingredient NameStrength
canada balsam 
cetyl alcohol 
anhydrous citric acid 
FD&C yellow no. 6 
ceteth-10 
propylene glycol 
stearalkonium chloride 
water 
isopropyl alcohol 
methylparaben 
propylparaben 
Product Characteristics
ColorORANGE (Light Orange) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-024-0259 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01991806/05/2009
Part 2 of 2
NIX 
tonics, dressings, and other hair grooming aids gel
Product Information
Route of AdministrationTOPICALDEA Schedule    
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRwater 
INGRpropylene glycol 
INGRglycerin 
INGRpolyquaternium-10 (1000 MPA.S at 2%) 
INGRdiazolidinyl urea 
INGRtrisodium citrate dihydrate 
INGRcitric acid monohydrate 
INGRmethylparaben 
INGRpropylparaben 
INGRedetate disodium 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01991811/15/2013
Labeler - Insight Pharmaceuticals (176792315)

Revised: 5/2013
 
Insight Pharmaceuticals

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