HAND SANITIZER- ethyl alcohol gel

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

ETHYL ALCOHOL 70%

Purpose

ANTISEPTIC

Uses

·To decrease bacteria on the skin that could cause disease.
·When water, soap and towel are not available.
·Recommended for repeated use.

Warnings

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

When using this product:

·Keep out of eyes, ears, or mouth.
·In case of eye contact, flush eyes thoroughly with water.
·Avoid contact with broken skin.
·Do not inhale or ingest.

Stop use and ask a doctor if

·Redness or irritation develop.
·Condition persists for more than 72 hours.

Keep out of reach of children.

·Children should be supervised by an adult when using this product.
·If swallowed, get medical help or contact a Poison Control Center right away.

Directions

·Spray product in your palm and rub hands together until dry.
·For children under 6, use only under adult supervision.
·Not recommended for infants.

Other Information

·Do not store above 105°F.
·May discolor some fabrics.
·Harmful to wood finishes and plastics.

Inactive Ingredients

Water, Glycerin, Dipropylene Glycol, Glycereth-26, Fragrance, Butylene Glycol, Leuconostoc/ Radish Root Ferment Filtrate, Aloe Barbadensis Leaf Juice, Phenoxyethanol.
May Contain: Red 40 Lake (CI 16035), Red 33 Lake (CI 17200), Red 4 Lake (CI 14700), Yellow 5 Lake (CI 19140:1), Blue 1 Lake (CI 42090:2).

85472-012

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85472-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	7 mL  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.40-0.70) (UNII: Y78AJD3DED)
FRAGRANCE 13576 (UNII: 5EM498GW35)
FD&C YELLOW NO. 5 ALUMINUM LAKE (UNII: JQ6BLH9FR7)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
TETRAHYDROXYPROPYL ETHYLENEDIAMINE (UNII: Q4R969U9FR)
D&C RED NO. 33 ALUMINUM LAKE (UNII: L3FT3LUT29)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85472-011-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	05/20/2026

Labeler - Zhejiang Gaorong Cosmetic Co., Ltd. (421318550)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang TR Technology Co., Ltd.		724485637	manufacture(85472-011)