Anti-Bacterial Hand Sanitizer by Fun Zone, Inc.

Anti-Bacterial Hand Sanitizer by

Drug Labeling and Warnings

Anti-Bacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Fun Zone, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTI-BACTERIAL HAND SANITIZER- ethyl alcohol gel 
Fun Zone, Inc.

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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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.

image of bottle label

ANTI-BACTERIAL HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69583-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69583-002-0029 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/12/201501/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/12/201501/01/2018
Labeler - Fun Zone, Inc. (803572929)

Revised: 2/2020
Document Id: 9e638fe9-107a-a454-e053-2995a90ae9b6
Set id: 25733a96-bfed-106d-e054-00144ff88e88
Version: 2
Effective Time: 20200212
 
Fun Zone, Inc.