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anti-bacterial hand gel by UniGroup Wholesale Inc.

Medically reviewed on September 25, 2017

Dosage form: gel
Ingredients: ALCOHOL 62mL in 100mL
Labeler: UniGroup Wholesale Inc.
NDC Code: 69358-0014

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 62%

Purpose Antiseptic

Warnings:For external use only.

Flammable. Keep away from fire or flame.

Stop use and ask for a doctor if irritation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a doctor right away.

Directions:
Pump as needed into your palms to cover hands. Rub hands together briskly until dry. Children under 6 years old should be supervised when using this product.

Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, FD&C Blue No.1, FD&C Yellow No.5, FD&C Red No.33, FD&C Red No.4.

Other Information: Store below 118 F.

UseTo help reduce bacteria on the skin

ANTI-BACTERIAL HAND GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69358-0014
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALOE VERA LEAF 
GLYCERIN 
PROPYLENE GLYCOL 
CARBOMER INTERPOLYMER TYPE A (55000 CPS) 
ULTRAMARINE BLUE 
AMINOMETHYL PROPANEDIOL 
LACTOSE 
CELLULOSE, MICROCRYSTALLINE 
SUCROSE 
STARCH, CORN 
ALPHA-TOCOPHEROL ACETATE 
HYPROMELLOSES 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
D&C RED NO. 33 
FD&C RED NO. 4 
Packaging
#Item CodePackage Description
1NDC:69358-0014-129 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/25/2015
Labeler - UniGroup Wholesale Inc. (079591424)

 
UniGroup Wholesale 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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