ALCOHOL-BASED DISINFECTANT HAND SANITIZER- alcohol-based disinfectant hand sanitizer gel 
GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD
Reference Label Set Id: a355641a-7b46-35a8-e053-2a95a90ae046

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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ALCOHOL-BASED DISINFECTANT HAND SANITIZER GEL

Active Ingredient(s)

Ethyl Alcohol 75%

Purpose

Antimicrobial

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.

• In children less than 2 months of age
• On open wounds

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

USE

• Place enough Product in your palm to thoroughly spread on both hands and rubinto the skin until dry.
• Children under 6 years of age should be supervised when using this product see full prescribing information for label

Package Label - Principal Display Panel

07021005000433010050108060309

ALCOHOL-BASED DISINFECTANT HAND SANITIZER 
alcohol-based disinfectant hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74757-002
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
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74757-002-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:74757-002-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:74757-002-02330 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:74757-002-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
5NDC:74757-002-05120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
6NDC:74757-002-06236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
7NDC:74757-002-07250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
8NDC:74757-002-08300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
9NDC:74757-002-091000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
10NDC:74757-002-102000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
11NDC:74757-002-113000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
12NDC:74757-002-124000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
13NDC:74757-002-135000 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 finalpart333A03/20/2020
Labeler - GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD (540725476)
Registrant - GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD (540725476)
Establishment
NameAddressID/FEIBusiness Operations
GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD540725476manufacture(74757-002)

Revised: 5/2020
Document Id: a6235797-9506-eb63-e053-2995a90a3162
Set id: a368d22e-dcd2-476d-e053-2995a90af881
Version: 3
Effective Time: 20200521
 
GUIZHOU XINZIHONG PHARMACEUTIC ADJUVANT CO.LTD