Medication Guide App

Mata Piojos A Pediculicide Low Foaming

Dosage form: shampoo
Ingredients: Pyrethrum Extract .12g in 60g, Piperonyl Butoxide 2.4g in 60g
Labeler: Apex International Mfg
NDC Code: 57501-865

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 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

  • 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 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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrethrum Extract (Pyrethrum Extract) Pyrethrum Extract.12 g  in 60 g
Piperonyl Butoxide (Piperonyl Butoxide) Piperonyl Butoxide2.4 g  in 60 g
Inactive Ingredients
Ingredient NameStrength
Water39.78 g  in 60 g
COCAMIDOPROPYL BETAINE14.2 g  in 60 g
POLYSORBATE 803.5 g  in 60 g
Packaging
#Item CodePackage Description
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/FEIOperations
Apex International Mfg015226132manufacture

Revised: 04/2010
 
Apex International Mfg

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)