KWORK ETHANOL DISINFECTION GEL- alcohol gel 
Zhejiang Quark Biotechnology 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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Active Ingredient(s)

Alcohol 75% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

Do not use

When using this product keep out of 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.

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

Other information

Inactive ingredients

Carbomer, Triethanciamine, Essence, purified water USP

Package Label - Principal Display Panel

60 mL NDC: 78867-002-01 60ml package label

100 mL NDC: 78867-002-02 100ml package label

480mL NDC: 78867-002-03 480ml package label

KWORK ETHANOL DISINFECTION GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78867-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S) 0.3 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78867-002-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:78867-002-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:78867-002-03480 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Zhejiang Quark Biotechnology Co., Ltd. (547091082)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Quark Biotechnology Co., Ltd.547091082manufacture(78867-002)

Revised: 6/2020
Document Id: a949a2d9-d9e9-7d6b-e053-2995a90a1e89
Set id: a949dcff-70da-2b43-e053-2a95a90a52df
Version: 1
Effective Time: 20200630
 
Zhejiang Quark Biotechnology Co., Ltd.