on Antibacterial by QUIMICA STOEVER S.A. DE C.V. Gel on Antibacterial

on Antibacterial by

Drug Labeling and Warnings

on Antibacterial by is a Otc medication manufactured, distributed, or labeled by QUIMICA STOEVER S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ON ANTIBACTERIAL- alcohol gel 
QUIMICA STOEVER S.A. DE C.V.

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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Gel on Antibacterial

Fact Chart

Active Ingredients:

Ethyl alcohol at 70%

Purpose:

Antiseptic

Uses:

Hand sanitizer to help reduce germs. For use when soap and water not available.

Warning:

For external use only. Flammable. Keep away from open flame and sources of heat or flame.

Do not use:

In children less than 2 months of age. On open skin wounds.

When using this product:

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask doctor:

If irritation or rash occurs, these may be signs of a serious condition.

Keep out of reach of children:

If swallowed, get medical help or contact a poison control center right away.

Directions:

Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Other information:

Store below 110°F (43°C). Keep the product indoors, in a cool, dry and ventilated area. Avoid freezing.

Inactive Ingredients:

Water, Carbomer, Triethanolamine, Glycerin

Package Labeling:

ON ANTIBACTERIAL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79675-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79675-000-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/15/2020	12/31/2021

Labeler - QUIMICA STOEVER S.A. DE C.V. (821341906)

Revised: 12/2021

Document Id: d3d34ccb-dec9-1c22-e053-2995a90aa88f

34390-5

Set id: abfe7de1-a467-4083-e053-2995a90a6b0a

Version: 2

Effective Time: 20211223