MATA PIOJOS LICE- piperonyl butoxide, pyrethrum extract shampoo

Mata Piojos Lice by

Drug Labeling and Warnings

Mata Piojos Lice by is a Otc medication manufactured, distributed, or labeled by Grandall Distributing Company Inc, WEEKS & LEO CO,INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purpose

Lice treatment

Uses

treat head, pubic (crab), and body lice

Warnings

For external use only

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.

Ask a doctor before use if you are

• allergic to regweed. May cause breathing difficulty or an asthmatic attack.

When using this product

• keep eyes tightly closed and protect eyes with a washcloth or towel
• if product gets in 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.

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 nick.
• 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 cut 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).
• hari 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 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

Other information

• do not freeze
• store at controlled room temperature, 20°C to 25°C (68° F to 77° F)
• to report serious side effects due to the use of this product call (515) 276-1586
• see package insert for additional information

Inactive ingredients

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

Package Labeling:

INGREDIENTS AND APPEARANCE

MATA PIOJOS LICE 
piperonyl butoxide, pyrethrum extract shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48201-367
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH)	PIPERONYL BUTOXIDE	40 mg  in 1 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV)	PYRETHRUM EXTRACT	3.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48201-367-00	1 in 1 BOX	06/01/2018
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358G	06/01/2018

Labeler - Grandall Distributing Company Inc (044428324)