![MATA PIOJOS A PEDICULICIDE LOW FOAMING (PYRETHRUM EXTRACT, PIPERONYL BUTOXIDE) SHAMPOO [APEX INTERNATIONAL MFG]](https://medic.hrt.org//dailymed/images/10d2838b-1bb2-47ef-a726-1ae087ce63c8/testSubmitImage1.jpg)
| NDC | 57501-865-02 |
| Set ID | 10d2838b-1bb2-47ef-a726-1ae087ce63c8 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Apex International Mfg |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART358G |
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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
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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