Grandall (as Pld) - Mata Piojos Lice Shampoo (48201-006)

Grandall (as Pld) - Mata Piojos Lice Shampoo (48201-006)
SPL v8
SPL
SPL Set ID 1de4e361-4e7b-4f7e-b6c8-30fa21e75bea
Route
TOPICAL
Published
Effective Date 2020-12-09
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
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-07-09

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

Section 51945-4

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 nitsif hair dries during combing, dampen slightly with waterfor 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)

Inactive Ingredients

water

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.


Structured Label Content

Uses

treats head, pubic (crab), and body lice

Section 51945-4 (51945-4)

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 nitsif hair dries during combing, dampen slightly with waterfor 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)

Inactive Ingredients (Inactive ingredients)

water

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.


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