UPW HAND SANITIZER- alcohol gel

UPW HAND SANITIZER by

Drug Labeling and Warnings

UPW HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by KUMSUNG ENC CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 58%

PURPOSE

Antiseptic

USE

Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

WARNINGS

For external use only. Flammable. Keep away form heat or flame

Do not use

- on infants less 2months of age

- on open skin wounds

WHEN USING THIS PRODUCT

keep away from eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE AND ASK A DOCTOR

if irritation or rash occurs. These may be signs of a serious condition

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

- Store between 1~30℃(33.8~86℉)

- Avoid freezing and excessive heat above 40℃(104℉)

INACTIVE INGREDIENTS

glycerin, 1,3-butylene glycol, carbomer940, triethanol amine, purified water USP

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

UPW HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80138-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	58 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80138-203-01	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/11/2020
2	NDC: 80138-203-02	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/11/2020

Labeler - KUMSUNG ENC CO., LTD (688082226)

Registrant - KUMSUNG ENC CO., LTD (688082226)

Establishment
Name	Address	ID/FEI	Business Operations
KUMSUNG ENC CO., LTD		688082226	manufacture(80138-203)