HAND SANITIZER GEL- alcohol liquid

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by SHENG HE TAI INTERNATIONAL TRADING CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 75%. Purpose: Antiseptic

Purpose

Antiseptic

Use

For hand-washing to decrease bacteria on the skin, only when water is not available.

Warnings

Flammable, keep away from fire or flames. For external use only.

WHEN USING

do not get into eyes

if contact occurs, rinse eyes thoroughly with water.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store in cool, dry place below 104F

Inactive ingredients

Alcohol, Aqua (Water), Butylene Glycol, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Eucalyptus Globulus Leaf Oil, Citrus Limon (Lemon) Peel Oil, Fragrance, o-CYMEN-5-OL, Ethylhexylglycerin, Chlorphenisin

Package Label - Principal Display Panel

80 mL NDC: 76584-004-08

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76584-004
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
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
WATER (UNII: 059QF0KO0R)
CHLORPHENESIN (UNII: I670DAL4SZ)
1,3-BUTYLENE GLYCOL 1-PROPIONATE (UNII: 17U77WTV66)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76584-004-08	80 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/30/2020

Labeler - SHENG HE TAI INTERNATIONAL TRADING CO., LTD. (656359732)

Establishment
Name	Address	ID/FEI	Business Operations
SHENG HE TAI INTERNATIONAL TRADING CO., LTD.		656359732	manufacture(76584-004)