Premier Value Brand Lice Killing Shampoo

Premier Value Brand Lice Killing Shampoo
SPL v3
SPL
SPL Set ID b3dc154a-e341-5632-e053-2995a90affb2
Route
TOPICAL
Published
Effective Date 2020-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Piperonyl Butoxide (4 g) Pyrethrum Extract (0.33 g)
Inactive Ingredients
Peg-25 Hydrogenated Castor Oil Alcohol Ammonium Laureth-2 Sulfate Polyquaternium-10 (400 Mpa.s At 2%) Water

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-12 Until 2029-12-31

Description

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

Purpose

Lice treatment


Medication Information

Purpose

Lice treatment

Description

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

Uses

treats head, pubic (crab), and body lice

Warnings

For external use only

Directions

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

Do Not Use

near eyes

inside nose, mouth, or vagina

on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

Active Ingredient

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Other Information

do not freeze

store at controlled room temperature 20°-25°C (68°-77°F)

see package insert for additional information

Inactive Ingredients

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

Principal Display Panel

Premier Value

Compare to the Active Ingredients in RID® Shampoo†

MAXIMUM STRENGTH

Lice Killing Shampoo

Lic Treatment Shampoo & Conditioner in One

Safe Effective & Fast Eliminates Lice from your Family

For Human Use

Includes one special comb

SHAMPOO 4 FL OZ (118 mL)

When Using This Product

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

Stop Use and Ask A Doctor If

breathing difficulty occurs

eye irritation occurs

skin or scalp irritation continues or infection occurs

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Are

allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

Consumer Information Package Insert


Structured Label Content

Uses

treats head, pubic (crab), and body lice

Purpose

Lice treatment

Warnings

For external use only

Directions

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

Do Not Use (Do not use)

near eyes

inside nose, mouth, or vagina

on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

Active Ingredient (Active ingredient)

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Other Information (Other information)

do not freeze

store at controlled room temperature 20°-25°C (68°-77°F)

see package insert for additional information

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

Premier Value

Compare to the Active Ingredients in RID® Shampoo†

MAXIMUM STRENGTH

Lice Killing Shampoo

Lic Treatment Shampoo & Conditioner in One

Safe Effective & Fast Eliminates Lice from your Family

For Human Use

Includes one special comb

SHAMPOO 4 FL OZ (118 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 eyes, flush with water right away

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

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

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

Consumer Information Package Insert (Consumer Information - Package Insert)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)