GEL SANITIZER- alcohol gel 
AAkron Rule Corporation

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 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.

Directions

Other information

Inactive ingredients

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

Product label

image descriptionimage description

GEL SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69394-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69394-004-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/28/2020
2NDC:69394-004-0289 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/28/2020
Labeler - AAkron Rule Corporation (002434389)

Revised: 7/2022
Document Id: e4b43c01-0a43-3fe8-e053-2a95a90a33cb
Set id: 34ece294-7ed7-42c3-a29f-9898c64a2509
Version: 2
Effective Time: 20220726
 
AAkron Rule Corporation