DRS CLEAN HAND GEL- alcohol gel
EROOM FACTORY Co., Ltd.

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

Ethanol, Deionized Water, 1,3-Butylene Glycol, Aloe Extract, Carbomer, Glycerine, Triethanolamine, Fragrance, Sodium Hyaluronate

Antimicrobial

KEEP OUT OF REACH OF THE CHILDREN

■ 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

label

DRS CLEAN HAND GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75193-0001
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75193-0001-1	500 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 - EROOM FACTORY Co., Ltd. (694819890)

Registrant - EROOM FACTORY Co., Ltd. (694819890)

Name	Address	ID/FEI	Business Operations
Establishment
EROOM FACTORY Co., Ltd.		694819890	manufacture(75193-0001)

Revised: 4/2020

Document Id: a31f053c-f050-0977-e053-2995a90a4ff0

Set id: a31ef289-6bab-c5f0-e053-2a95a90a0557

Version: 1

Effective Time: 20200412

EROOM FACTORY Co., Ltd.