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

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.

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Drug Facts

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


Ask a doctor before use if you have

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

Directions


Test Submit Image

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.


MATA PIOJOS  A PEDICULICIDE LOW FOAMING
pyrethrum extract, piperonyl butoxide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57501-865
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrethrum Extract (UNII: ZUM06L90GV) (Pyrethrum Extract - UNII:ZUM06L90GV) Pyrethrum Extract.12 g  in 60 g
Piperonyl Butoxide (UNII: LWK91TU9AH) (Piperonyl Butoxide - UNII:LWK91TU9AH) Piperonyl Butoxide2.4 g  in 60 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57501-865-0260 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G04/23/2010
Labeler - Apex International Mfg (015226132)
Registrant - Apex International Mfg (015226132)
Establishment
NameAddressID/FEIBusiness Operations
Apex International Mfg015226132manufacture

Revised: 4/2010
Document Id: 10d2838b-1bb2-47ef-a726-1ae087ce63c8
Set id: 10d2838b-1bb2-47ef-a726-1ae087ce63c8
Version: 1
Effective Time: 20100423
 
Apex International Mfg