MATA PIOJOS A PEDICULICIDE LOW FOAMING- pyrethrum extract, piperonyl butoxide shampoo

Mata Piojos by

Drug Labeling and Warnings

Mata Piojos by is a Otc medication manufactured, distributed, or labeled by Apex International Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Drug Facts

Active Ingredients        Purpose
Pyrethrins 0.33%
Piperonyl Butoxide 4%........Pedicullicide

Uses
For the treatment of Head, Body, Pubic (Crab) Lice.

Warnings
For external use only.

Allergy alert:
Use with caution on persons allergic to ragweed.

Do not use

• near eyes or permit contact with mucous membranes, such as inside the nose, mouth, or vagina.

Ask a doctor before use if you have

• Skin irritation or infection
• Infected eyebrows or eyelashes

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

• SHAKE WELL BEFORE USE
• Use on DRY hair.
• Apply to affected area until all hair is thoroughly wet with product
• Allow product to remain on for 10 minutes but no longer.

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Pyrethrum Extract equivalent to 0.33% Pyrethrins

Piperonyl Butoxide 4% equivalent to min. 3.2%

(butylcarbityl)(6-propylpiperonyl) ether and 0.8% related compounds.

INGREDIENTS AND APPEARANCE

MATA PIOJOS  A PEDICULICIDE LOW FOAMING
pyrethrum extract, piperonyl butoxide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57501-865
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrethrum Extract (UNII: ZUM06L90GV) (Pyrethrum Extract - UNII:ZUM06L90GV)	Pyrethrum Extract	.12 g  in 60 g
Piperonyl Butoxide (UNII: LWK91TU9AH) (Piperonyl Butoxide - UNII:LWK91TU9AH)	Piperonyl Butoxide	2.4 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)	39.78 g  in 60 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	14.2 g  in 60 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	3.5 g  in 60 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57501-865-02	60 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358G	04/23/2010

Labeler - Apex International Mfg (015226132)

Registrant - Apex International Mfg (015226132)

Establishment
Name	Address	ID/FEI	Business Operations
Apex International Mfg		015226132	manufacture