GEL SANITIZER- alcohol gel

Gel Sanitizer by

Drug Labeling and Warnings

Gel 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 70% 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 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. If swallowed, get medical help and call Poison Control.

KEEP OUT OF REACH OF CHILDREN

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 excessive heat above 40C (104F)

Inactive ingredients

Aloe Vera, Carbomer, D&C Green #5, D&C Yellow #10, Water, Trolamine

Product label

INGREDIENTS AND APPEARANCE

GEL SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69394-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69394-004-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/28/2020
2	NDC: 69394-004-02	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)