HAND SANITIZER 7- alcohol gel
Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

alcohol

to decrease bacteria on the skin that could cause disease

KEEP OUT OF REACH OF THE CHILDREN

take appropriate amount on the hand, rub and dry well

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

for external use only

Purified water, Ethanol, Glycerine, Triethyleneamine, Carbomer, Fragrance(lemon)

label

HAND SANITIZER 7
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75695-0004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75695-0004-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/06/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/06/2020

Labeler - Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch (695625894)

Registrant - Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch (695625894)

Name	Address	ID/FEI	Business Operations
Establishment
Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch		695625894	manufacture(75695-0004)

Revised: 6/2020

Document Id: a764522b-8f91-c56c-e053-2a95a90a72ba

Set id: a7645a35-6c8f-ebd0-e053-2995a90a2ad8

Version: 1

Effective Time: 20200606

Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch