Nix Complete Lice Treatment Kit

Nix Complete Lice Treatment Kit
SPL v3
SPL
SPL Set ID cca42777-01bf-4352-acdb-441160d69557
Route
TOPICAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Permethrin (280 mg)
Inactive Ingredients
Methylparaben Propylparaben Canada Balsam Cetyl Alcohol Anhydrous Citric Acid Fd&c Yellow No. 6 Hydroxyethyl Cellulose, Unspecified Ceteth-10 Propylene Glycol Stearalkonium Chloride Water Isopropyl Alcohol Polyquaternium-10 (125 Mpa.s At 2%) Glycerin Diazolidinyl Urea Trisodium Citrate Dihydrate Citric Acid Monohydrate Edetate Disodium Anhydrous

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
NDA Active Since 2013-11-15

Description

[1 Eliminate] Creme Rinse Drug Facts

Purpose

Lice treatment


Medication Information

Purpose

Lice treatment

Description

[1 Eliminate] Creme Rinse Drug Facts

Uses

treats head lice

Section 42229-5

[1 Eliminate] Creme Rinse

Drug Facts

Warnings

For external use only

Directions

Important: Read warnings before use

  • Adults and children 2 months old and older

Inspect

  • 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/or nits (eggs)

  • use a tool, such as a comb or two unsharpened pencils to lift and part the hair

  • look for tiny nits near scalp, beginning at back of neck and behind 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 (or eggs) 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
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.
Questions?

1-888-542-3546

[ 2 Remove] Combing Gel & Comb

Product Facts

Ingredients

water, propylene glycol, glycerin, polyquaternium-10, diazolidinyl urea, hydroxyethylcellulose, sodium citrate dihydrate, citric acid, methylparaben, propylparaben, disodium EDTA

[3 Control] Nix ® Lice Control Spray

Other Information
  • Nix Combing Gel does not kill lice and nits

  • Pesticide free

  • Keep carton for full information and warnings. Read all warnings and directions before use.

  • Visit our website at nixlice.com
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)
Active Ingredient:

PERMETHRIN 0.25%

(CAS # 52645-53-1)

Other Ingredients:

99.75%

100.00%

NOT FOR USE ON HUMANS. READ ENTIRE LABEL BEFORE EACH USE. SHAKE BOTTLE WELL BEFORE USING.

Precautionary Statements

Hazards to Humans and Domestic Animals 

Caution User Safety Recommendations:  Wear long-sleeved shirt and long pants, socks and shoes. User should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet. User should remove clothing immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.

Directions For Use

It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

User Restrictions: For use as a surface spray, do not allow adults, children or pets to enter until sprays have dried. Do not apply as a broadcast treatment to indoor surfaces at residential sites, including nurseries, day care centers, schools, hospitals and nursing homes. 

FOR USE IN NON-FOOD AREAS INDOORS AND OUTSIDE PREMISES OF HOMES, HOBBY GREENHOUSES AND STORAGE BUILDINGS, CAMPERS, MOBILE HOMES, AUTOMOBILES, TRUCKS AND BOATS.     

Indoor Application

In the home, cover all food handling surfaces, cover or remove all food and cooking utensils or wash thoroughly after treatment. Application is prohibited directly into sewers or drains, or to any area like a gutter where drainage to sewers, storm drains, water bodies, or aquatic habitat can occur. Do not allow the product to enter any drain during or after application. Do not enter or allow others to enter until sprays have dried.  

Surface Spraying: To kill   lice   and nits/ louse eggs : Treat only those garments and parts of bedding, including mattresses and furniture that cannot be either laundered or dry cleaned. Spray in an inconspicuous area to test for possible staining or discoloration. Inspect again after drying, then proceed to spray entire area to be treated. Spray from a distance of 8 to 10 inches. Allow all treated articles to dry thoroughly before use. 

 

To kill bedbugs: Spray mattresses lightly, particularly around tufts and seams. Take beds apart and spray in all joints. Allow all sprayed articles to dry thoroughly before use. 

Storage and Disposal

P esticide Storage: Keep from freezing. Store upright at room temperature, out of reach of children and pets.  

Pesticide Disposal: If partly filled – Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoor drain.  

Container Handling: If empty – Nonrefillable container. Do not reuse or refill this container. Place in trash or offer for recycling if available. 

NOTICE:  To the extent consistent with applicable law, buyer assumes all risks of use, storage or handling of this product not in strict accordance with directions given herewith.  

EPA REG. NO. 64321-1-75406

EPA EST. NO. 91705-NJ-001

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, methylparaben, propylparaben

Principal Display Panel

Nix ®  Complete Lice Treatment Kit

Permethrin Creme Rinse (1%)



Creme Rinse 2 Bottles 2 fl oz (59 mL) EACH, Combing Gel 2 fl oz (59 mL), Lice Comb, Lice Control Spray 5 fl oz (147.86 mL)

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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Are
  • allergic to ragweed. May cause breathing difficulty or an asthmatic episode.
Active Ingredient (in Each Fluid Ounce)

Permethrin 280 mg (1%)


Structured Label Content

Uses

treats head lice

Section 42229-5 (42229-5)

[1 Eliminate] Creme Rinse

Drug Facts

Purpose

Lice treatment

Warnings

For external use only

Directions

Important: Read warnings before use

  • Adults and children 2 months old and older

Inspect

  • 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/or nits (eggs)

  • use a tool, such as a comb or two unsharpened pencils to lift and part the hair

  • look for tiny nits near scalp, beginning at back of neck and behind 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 (or eggs) 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
Do Not Use (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.
Questions?

1-888-542-3546

[ 2 Remove] Combing Gel & Comb

Product Facts

Ingredients

water, propylene glycol, glycerin, polyquaternium-10, diazolidinyl urea, hydroxyethylcellulose, sodium citrate dihydrate, citric acid, methylparaben, propylparaben, disodium EDTA

[3 Control] Nix ® Lice Control Spray

Other Information
  • Nix Combing Gel does not kill lice and nits

  • Pesticide free

  • Keep carton for full information and warnings. Read all warnings and directions before use.

  • Visit our website at nixlice.com
Other Information (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)
Active Ingredient: (Active ingredient:)

PERMETHRIN 0.25%

(CAS # 52645-53-1)

Other Ingredients: (Other ingredients:)

99.75%

100.00%

NOT FOR USE ON HUMANS. READ ENTIRE LABEL BEFORE EACH USE. SHAKE BOTTLE WELL BEFORE USING.

Precautionary Statements

Hazards to Humans and Domestic Animals 

Caution User Safety Recommendations:  Wear long-sleeved shirt and long pants, socks and shoes. User should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet. User should remove clothing immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.

Directions For Use

It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

User Restrictions: For use as a surface spray, do not allow adults, children or pets to enter until sprays have dried. Do not apply as a broadcast treatment to indoor surfaces at residential sites, including nurseries, day care centers, schools, hospitals and nursing homes. 

FOR USE IN NON-FOOD AREAS INDOORS AND OUTSIDE PREMISES OF HOMES, HOBBY GREENHOUSES AND STORAGE BUILDINGS, CAMPERS, MOBILE HOMES, AUTOMOBILES, TRUCKS AND BOATS.     

Indoor Application

In the home, cover all food handling surfaces, cover or remove all food and cooking utensils or wash thoroughly after treatment. Application is prohibited directly into sewers or drains, or to any area like a gutter where drainage to sewers, storm drains, water bodies, or aquatic habitat can occur. Do not allow the product to enter any drain during or after application. Do not enter or allow others to enter until sprays have dried.  

Surface Spraying: To kill   lice   and nits/ louse eggs : Treat only those garments and parts of bedding, including mattresses and furniture that cannot be either laundered or dry cleaned. Spray in an inconspicuous area to test for possible staining or discoloration. Inspect again after drying, then proceed to spray entire area to be treated. Spray from a distance of 8 to 10 inches. Allow all treated articles to dry thoroughly before use. 

 

To kill bedbugs: Spray mattresses lightly, particularly around tufts and seams. Take beds apart and spray in all joints. Allow all sprayed articles to dry thoroughly before use. 

Storage and Disposal

P esticide Storage: Keep from freezing. Store upright at room temperature, out of reach of children and pets.  

Pesticide Disposal: If partly filled – Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoor drain.  

Container Handling: If empty – Nonrefillable container. Do not reuse or refill this container. Place in trash or offer for recycling if available. 

NOTICE:  To the extent consistent with applicable law, buyer assumes all risks of use, storage or handling of this product not in strict accordance with directions given herewith.  

EPA REG. NO. 64321-1-75406

EPA EST. NO. 91705-NJ-001

Inactive Ingredients (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, methylparaben, propylparaben

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Nix ®  Complete Lice Treatment Kit

Permethrin Creme Rinse (1%)



Creme Rinse 2 Bottles 2 fl oz (59 mL) EACH, Combing Gel 2 fl oz (59 mL), Lice Comb, Lice Control Spray 5 fl oz (147.86 mL)

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Are (Ask a doctor before use if you are)
  • allergic to ragweed. May cause breathing difficulty or an asthmatic episode.
Active Ingredient (in Each Fluid Ounce) (Active ingredient (in each fluid ounce))

Permethrin 280 mg (1%)


Advanced Ingredient Data


Raw Label Data

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