HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ETHYL alcohol 65% v/v. Purpose: Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

USES

• 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. Flammable. Keep away from heat or flame.

DO NOT USE

near or in the eyes. If contact occurs, rinse eyes with water throughly.

STOP USE

Stop use and ask a physician if irritation,rash, or redness develops.

KEEP OUT OF REACH OF CHILDREN

If swallowed get medical help or contact a Poison Control Center right away.

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

• Should be stored below 110℉(43℃)
• Can discolor surfaces and some fabrics

INACTIVE INGREDIENTS

deionized water, aminomethyl propanol, carbomer, propanediol, tocopheryl acetate, isopropyl myristate, glycerin, fragrance, water

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

500mL NDC: 75328-002-01

946mL NDC: 75328-002-02

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75328-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPANEDIOL (UNII: 5965N8W85T)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75328-002-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/27/2020
2	NDC: 75328-002-02	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/27/2020

Labeler - YANGZHOU BEAUTY COSMETICS CO., LTD (542978427)

Establishment
Name	Address	ID/FEI	Business Operations
YANGZHOU BEAUTY COSMETICS CO., LTD		542978427	manufacture(75328-002)