KWORK ETHANOL DISINFECTION-SPRAY- alcohol spray 
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% v/v. 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

Inactive ingredients

purified water USP

Other information

Package Label - Principal Display Panel

60 mL NDC: 78867-001-01 60ml package label

100 mL NDC: 78867-001-02 100ml package label

480mL NDC: 78867-001-03 480 package label

KWORK ETHANOL DISINFECTION-SPRAY 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78867-001
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
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78867-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:78867-001-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:78867-001-03480 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(78867-001)

Revised: 5/2020
Document Id: a69f09e0-a010-3997-e053-2a95a90a157e
Set id: a8842217-47d0-256b-e053-2995a90a8141
Version: 1
Effective Time: 20200527
 
Zhejiang Quark Biotechnology Co., Ltd.