ALCOHOL SANITIZING WIPES- alcohol cloth 
Guangzhou Baihua 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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Purpose

Antiseptic, Alcohol Sanitizing Wipes

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

This is a sanitizing wipe manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The sanitizing wipe is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Use

Alcohol Sanitizing Wipes to help reduce bacteria on skin. 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

glycerin, hydrogen peroxide, RO pure water

Package Label - Principal Display Panel

80 wipes b NDC: 77665-101-07

Alcohol Sanitizing Wipes 80 b Label

60 wipes b NDC: 77665-101-06

Alcohol Sanitizing Wipes 60 b Label

50 wipes b NDC: 77665-101-05

Alcohol Sanitizing Wipes 50 b Label

100 wipes NDC: 77665-101-04

Alcohol Sanitizing Wipes 100 Label

1 wipe NDC: 77665-101-03

Alcohol Sanitizing Wipe 1

10 wipes NDC: 77665-101-02

Alcohol Sanitizing Wipes 10

50 wipes NDC: 77665-101-01 50 wipes label

ALCOHOL SANITIZING WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77665-101
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
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:77665-101-0150 mL in 1 PACKAGE; Type 0: Not a Combination Product05/13/2020
2NDC:77665-101-0210 mL in 1 PACKAGE; Type 0: Not a Combination Product05/21/2020
3NDC:77665-101-031 mL in 1 PACKAGE; Type 0: Not a Combination Product05/21/2020
4NDC:77665-101-04100 mL in 1 CANISTER; Type 0: Not a Combination Product05/30/2020
5NDC:77665-101-0550 mL in 1 PACKAGE; Type 0: Not a Combination Product06/02/2020
6NDC:77665-101-0660 mL in 1 PACKAGE; Type 0: Not a Combination Product06/18/2020
7NDC:77665-101-0780 mL in 1 PACKAGE; Type 0: Not a Combination Product06/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/13/2020
Labeler - Guangzhou Baihua Co., Ltd. (545015588)
Registrant - Guangzhou Baihua Co., Ltd. (545015588)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Baihua Co., Ltd545015588manufacture(77665-101)

Revised: 12/2021
Document Id: d3507fbb-744e-e1da-e053-2a95a90a78a7
Set id: a58a5e48-a093-3e5f-e053-2995a90ac8cb
Version: 6
Effective Time: 20211216
 
Guangzhou Baihua Co., Ltd.