HAND CLEANER- 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

sterilization of hands, skin and so on

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

glycerin, isopropyl myristate, carbomer, trolamine, propylene glycol, acoe x, water

label

HAND CLEANER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75695-0001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 940 (UNII: 4Q93RCW27E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75695-0001-1	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020
2	NDC:75695-0001-2	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/01/2020

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(75695-0001)

Revised: 4/2020

Document Id: a3c79bb4-cd3b-9fd3-e053-2a95a90ac25f

Set id: a3bf1737-c7ec-01ac-e053-2a95a90a2ef4

Version: 2

Effective Time: 20200421

Sangji Enterprise Co LTD Cheongwon Oriental Medical Cosmetic Branch