SUNGSU CLEAN HAND SANITIZER- alcohol gel

SUNGSU Clean Hand Sanitizer by

Drug Labeling and Warnings

SUNGSU Clean Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SUNGSUBIOTEK CO. LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Alcohol 62% v/v

INACTIVE INGREDIENTS

Aloe Extract, Butylene Glycol, CARBOMER, DL-Panthenol, Polyoxyethylene Hydrogenetated Caster Oil, Triethanolamine, Water

PURPOSE

Antiseptic

WARNINGS

For external use only. Flammable. Keep away from heat or flame
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Do not use
in children less than 2 months of age
on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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

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

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.

Directions

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.
Supervise children in the use of this product.

Other information

Store between 59-86℉ (15-30℃)
Avoid freezing and excessive heat above 104℉ (40℃)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNGSU CLEAN HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80454-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	Alcohol	310 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
Butylene Glycol (UNII: 3XUS85K0RA)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PANTHENOL (UNII: WV9CM0O67Z)
TROLAMINE (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80454-030-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020

Labeler - SUNGSUBIOTEK CO. LTD. (690452683)

Registrant - SUNGSUBIOTEK CO. LTD. (690452683)

Establishment
Name	Address	ID/FEI	Business Operations
SUNGSUBIOTEK CO. LTD.		690452683	manufacture(80454-030)