HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by HIGH 5 HANDS LLC, Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

Ethyl Alcohol 75%

PURPOSE

Purpose
Antiseptic

INDICATIONS & USAGE

USES

Decreases bacteria on hands.

WARNINGS

WARNINGS

For external use only. Flammable. Keep away

from fire or flame. Avoid contact with broken skin.

DO NOT USE

Do not use in or near the eyes. In case of contact, flush thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help.

DOSAGE & ADMINISTRATION

DIRECTIONS

Wet hands thoroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised. Not recommended for infants.

STORAGE AND HANDLING

OTHER INFORMATION

Do not store above 110°F. May discolor some fabrics.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

Acrylate/C10-30 Alkyl Acrylate crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl propanol,

Denatonium benzoate, Fragrance (Parfum), Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water (Aqua)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78869-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78869-002-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/10/2020

Labeler - HIGH 5 HANDS LLC (117533415)

Registrant - Nantong Health & Beyond Hygienic Products Inc. (421280161)