Sanitizer by AAkron Rule Corporation SANITIZER- alcohol gel

Sanitizer by

Drug Labeling and Warnings

Sanitizer by is a Otc medication manufactured, distributed, or labeled by AAkron Rule Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 80% v/v

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on skin.

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product avoid mouth, eyes and ears. In case of contact with eyes, flush with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help and call Poison Control.

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age.

Other information

• Store in 15-30C (59-86F)
• Avoid freezing and above 40C (104F)

Inactive ingredients

Water,Glycerin, Thickener, Ph balancer, Fragrance

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69394-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CETEARETH-5 (UNII: 2AAD28764Q)
CYCLOHEXANE (UNII: 48K5MKG32S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69394-002-01	29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/28/2020
2	NDC: 69394-002-02	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/28/2020

Labeler - AAkron Rule Corporation (002434389)