Label: MATA PIOJOS A PEDICULICIDE LOW FOAMING- pyrethrum extract, piperonyl butoxide shampoo
-
Contains inactivated NDC Code(s)
NDC Code(s): 57501-865-02 - Packager: Apex International Mfg
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 23, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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
-
INGREDIENTS AND APPEARANCE
MATA PIOJOS A PEDICULICIDE LOW FOAMING
pyrethrum extract, piperonyl butoxide shampooProduct 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