FIRSTHAND ADVANTAGE PREMIUM SANITIZER- alcohol gel

FirstHand Advantage Premium Sanitizer by

Drug Labeling and Warnings

FirstHand Advantage Premium Sanitizer by is a Otc medication manufactured, distributed, or labeled by Age Advantage Brands LLC, Fresh & Beautiful Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

FIRSTHAND ADVANTAGE PREMIUM SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79215-101
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79215-101-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
2	NDC: 79215-101-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020
3	NDC: 79215-101-99	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/07/2020

Labeler - Age Advantage Brands LLC (088956468)

Establishment
Name	Address	ID/FEI	Business Operations
Fresh & Beautiful Cosmetics		117409349	MANUFACTURE(79215-101)