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Anti-Bacterial Hand Sanitizer by Fun Zone, Inc.

Dosage form: gel
Ingredients: ALCOHOL 62mL in 100mL
Labeler: Fun Zone, Inc.
NDC Code: 69583-002

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.

Active Ingredient:
Ethyl Alcohol 63%

Purpose:
Antiseptic

Warnings:
For external use only. Flammable, keep away from fire, flame and direct sunlight.

Stop using this product and consult a doctor If irritation or redness develops.Stop using this product and consult a doctor If irritation or redness develops.

Directions

  • Rub dime sized amount between hands until dry.
  • For use by children under 6 years, adult supervision is required.

Water, Propylene Glycol, Carbomer, Aminomethyl Propanol, Glycerin, Denotonium Benzoate

Uses To help reduce bacteria on hands.


When using this product Avoid contact with eyes and lips. If contact occurs, rinse with water.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

ANTI-BACTERIAL HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69583-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PROPYLENE GLYCOL 
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 
AMINOMETHYLPROPANOL 
DENATONIUM BENZOATE 
Packaging
#Item CodePackage Description
1NDC:69583-002-0029 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/12/2015
Labeler - Fun Zone, Inc. (803572929)

Revised: 11/2015
 
Fun Zone, Inc.

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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.

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