(QIQING) CHLORHEXIDINE GLUCONATE ALCOHOL DISINFECTANT- alcohol liquid 
Qingdao precision medical technology co., LTD. Zibo 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.

----------

Chlorhexidine Gluconate Alcohol Disinfectant-Precision

Purpose

Antiseptic-Antiseptic

Active Ingredient(s)

Alcohol 63%-77% v/v. Purpose: Antiseptic

Chlorhexidine Gluconate 0.45%-0.55% w/v Purpose: Antiseptic

Use

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

50 mL NDC: 77919-001-01

60 mL NDC: 77919-001-02

100 mL NDC: 77919-001-03 100ml

250 mL NDC: 77919-001-04

500 mL NDC: 77919-001-05

1000 mL NDC: 77919-001-06

(QIQING) CHLORHEXIDINE GLUCONATE ALCOHOL DISINFECTANT 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77919-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE0.45 mg  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77919-001-0150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
2NDC:77919-001-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
3NDC:77919-001-03100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
4NDC:77919-001-04250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
5NDC:77919-001-05500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
6NDC:77919-001-061000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/2020
Labeler - Qingdao precision medical technology co., LTD. Zibo branch (554534589)
Registrant - Qingdao precision medical technology co., LTD. Zibo branch (554534589)
Establishment
NameAddressID/FEIBusiness Operations
Qingdao precision medical technology co., LTD. Zibo branch554534589manufacture(77919-001)

Revised: 5/2020
Document Id: a5aac064-ade5-e1a7-e053-2a95a90a93be
Set id: a5aac064-adf3-e1a7-e053-2a95a90a93be
Version: 1
Effective Time: 20200515
 
Qingdao precision medical technology co., LTD. Zibo branch