Quality Choice Lice Treatment Kit

Quality Choice Lice Treatment Kit
SPL v10
SPL
SPL Set ID 1f4392ba-f405-7ee1-e063-6394a90ae631
Route
TOPICAL
Published
Effective Date 2023-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Piperonyl Butoxide (40 mg) Pyrethrum Extract (3.3 mg)
Inactive Ingredients
Polyquaternium-10 (400 Mpa.s At 2%) Ammonium Laureth-2 Sulfate Alcohol Water Peg-25 Hydrogenated Castor Oil

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-09

Description

Piperonyl butoxide 4% Pyrethrum extract (equivalent to 0.33% pyrethrins)


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

treats head, pubic (crab), and body lice

Dosage and Administration
  • Important: Read warnings before use
  • Adults and children 2 years and over:

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 this product

Treat

  • apply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck.
  • allow product to remain for 10 minutes, but no longer
  • use warm water to form a lather, shampoo, then thoroughly rinse
  • for head lice, towel dry hair and comb out tangles

Remove lice and their eggs (nits)

  • use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove).
  • hair should remain slightly damp while removing nits
  • if hair dries during combing, dampen slightly with water
  • for head lice, part hair into sections. Do one section at a time starting on top of the head. Longer hair may take 1 to 2 hours.
  • lift a 1-to 2-inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp.
  • pin back each strand of hair after combing
  • clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back.
  • after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.
  • check daily for any lice/nits that you missed
  • a second treatment must be done in 7 to 10 days to kill any newly hatched lice
  • if infestation continues, see a doctor for other treatments
  • Children under 2 years: ask a doctor
Description

Piperonyl butoxide 4% Pyrethrum extract (equivalent to 0.33% pyrethrins)

Section 42230-3

Section 44425-7
  • do not freeze
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • see package insert for additional information
Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9
  • breathing difficulty occurs
  • eye irritation occurs
  • skin or scalp irritation continues or infection occurs
Section 50567-7
  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets into eyes, flush with water right away
  • scalp itching or redness may occur
Section 50569-3
  • allergic to ragweed. May cause breathing difficulty or an asthmatic attack.
Section 50570-1
  • near eyes
  • inside nose, mouth, or vagina
  • on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.
Section 51945-4

Quality Choice

The all in one lice solution for your family

Compare to the Active Ingredients in RID® Shampoo†

with maximum strength Shampoo

1 treat shampoo

2 remove comb/gel

3 control spray

Instrucciones en español incluidas

Section 55105-1

Lice treatment

Section 55106-9

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Inactive Ingredients

ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol


Structured Label Content

Indications and Usage (34067-9)

treats head, pubic (crab), and body lice

Dosage and Administration (34068-7)
  • Important: Read warnings before use
  • Adults and children 2 years and over:

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 this product

Treat

  • apply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck.
  • allow product to remain for 10 minutes, but no longer
  • use warm water to form a lather, shampoo, then thoroughly rinse
  • for head lice, towel dry hair and comb out tangles

Remove lice and their eggs (nits)

  • use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove).
  • hair should remain slightly damp while removing nits
  • if hair dries during combing, dampen slightly with water
  • for head lice, part hair into sections. Do one section at a time starting on top of the head. Longer hair may take 1 to 2 hours.
  • lift a 1-to 2-inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp.
  • pin back each strand of hair after combing
  • clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back.
  • after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.
  • check daily for any lice/nits that you missed
  • a second treatment must be done in 7 to 10 days to kill any newly hatched lice
  • if infestation continues, see a doctor for other treatments
  • Children under 2 years: ask a doctor
Warnings and Precautions (34071-1)

For external use only

Section 42230-3 (42230-3)

Section 44425-7 (44425-7)
  • do not freeze
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • see package insert for additional information
Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)
  • breathing difficulty occurs
  • eye irritation occurs
  • skin or scalp irritation continues or infection occurs
Section 50567-7 (50567-7)
  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets into eyes, flush with water right away
  • scalp itching or redness may occur
Section 50569-3 (50569-3)
  • allergic to ragweed. May cause breathing difficulty or an asthmatic attack.
Section 50570-1 (50570-1)
  • near eyes
  • inside nose, mouth, or vagina
  • on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.
Section 51945-4 (51945-4)

Quality Choice

The all in one lice solution for your family

Compare to the Active Ingredients in RID® Shampoo†

with maximum strength Shampoo

1 treat shampoo

2 remove comb/gel

3 control spray

Instrucciones en español incluidas

Section 55105-1 (55105-1)

Lice treatment

Section 55106-9 (55106-9)

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Inactive Ingredients (Inactive ingredients)

ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol


Advanced Ingredient Data


Raw Label Data

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