AFFEX CARE HAND SANITIZER- alcohol gel 
Autotrol 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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Hand Sanitizer

Ethyl Alcohol 70% v/v

Antiseptic

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Flammable. Keep away from heat or flame

For external use only.

place enough product in your palm to thoroughly cover your hands
rub hands together briskly until dry
children under 6 years of age should be supervised when using this product

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

Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a physician if skin irritation or rash develops.

Water, Glycerin, Carbomer, Aloe, Tocopheryl Acetate

3785 mL NDC: 79097-020-28 1 Gallon Label

AFFEX CARE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79097-023
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 (UNII: V5VD430YW9)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79097-023-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
2NDC:79097-023-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
3NDC:79097-023-03100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
4NDC:79097-023-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
5NDC:79097-023-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
6NDC:79097-023-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
7NDC:79097-023-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
8NDC:79097-023-283785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
9NDC:79097-023-751000000 mL in 1 TANK; Type 0: Not a Combination Product07/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/13/2020
Labeler - Autotrol Corporation (001755131)
Establishment
NameAddressID/FEIBusiness Operations
Autotrol Corporation001755131label(79097-023) , manufacture(79097-023) , pack(79097-023)

Revised: 12/2021
Document Id: d27e5921-f82e-14fb-e053-2a95a90a119c
Set id: b0f17440-6af9-767f-e053-2a95a90a7272
Version: 5
Effective Time: 20211206
 
Autotrol Corporation