FIRSTHAND ADVANTAGE PREMIUM SANITIZER- alcohol gel 
Age Advantage Brands LLC

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

Drug Facts:

Active Ingredients:

Ethyl Alcohol 70%

Purpose

Antibacterial

USE:

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

WARNINGS:

For external use only

Keep out of reach of Children

If swallowed, get medical help or contact a poison control center immediately

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 a doctor if irritation or rash occurs. These may be signs of a serious condition.

DIRECTIONS:

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.

OTHER INFORMATION:

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

INACTIVE INGREDIENTS:

Water, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Glycerin, Tocopheryl Acetate (Vitamin E), Acrylates/C10-30 Alkyl Acrylate Crosspolmer, Aminomethyl Propanol.

Principal Display Panel – 1 Gallon Bottle Label

AGE ADVANTAGE®

SKIN CARE

FIRST HAND
ADVANTAGE

Kills 99.9%
of Germs

PREMIUM
SANITIZER

moisturizing formula with aloe

ONE GALLON

Principal Display Panel – 1 Gallon Bottle Label
FIRSTHAND ADVANTAGE PREMIUM SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79215-101
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
Water (UNII: 059QF0KO0R)  
Butyl Acrylate/Methyl Methacrylate/Methacrylic Acid Copolymer (18000 MW) (UNII: JZ1374NL9E)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Glycerin (UNII: PDC6A3C0OX)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
Aminomethylpropanol (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79215-101-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
2NDC:79215-101-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
3NDC:79215-101-993785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/07/2020
Labeler - Age Advantage Brands LLC (088956468)
Establishment
NameAddressID/FEIBusiness Operations
Fresh & Beautiful Cosmetics117409349MANUFACTURE(79215-101)

Revised: 5/2020
Document Id: bc28d944-d784-4eb6-9616-f3cd698d79d7
Set id: f964639b-5642-43dd-a0d2-545fde5cc1c8
Version: 1
Effective Time: 20200514
 
Age Advantage Brands LLC