HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Atara Holdings Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Ethyl Alcohol 62%

PURPOSE

Purpose
Antiseptic

WARNINGS

Warnings

For external use only. Flammable. Keep away from fire or flame.

STOP USE

Stop use and ask a doctor if irritation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

Pump as needed into your palms to cover hands. Rub hands together briskly unitl dry. Children under 6 years old should be supervised when using this product.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Fragrance, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, D&C Red No.33, FD&C Blue No.1.

INDICATIONS & USAGE

Uses

To help reduce bacteria on the skin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71154-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
LACTOSE (UNII: J2B2A4N98G)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)
STARCH, CORN (UNII: O8232NY3SJ)
ULTRAMARINE BLUE (UNII: I39WR998BI)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYPROMELLOSES (UNII: 3NXW29V3WO)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71154-001-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/24/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/24/2016

Labeler - Atara Holdings Inc (080473576)