75%ALCOHOL WIPES- alcohol cloth 
Guangzhou Guangsan Biopharma 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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75%ALCOHOL WIPES

75%ALCOHOL WIPES

Active Ingredient(s)

Alcohol 4.75g/pcs. Purpose: Antiseptic

Purpose

Antiseptic, 75%ALCOHOL WIPES

Use

75%ALCOHOL WIPES 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

purified water USP

Package Label - Principal Display Panel

308050106040

75%ALCOHOL WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80292-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL4.75 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80292-101-0110 in 1 BAG; Type 0: Not a Combination Product03/30/2020
2NDC:80292-101-0230 in 1 BAG; Type 0: Not a Combination Product03/30/2020
3NDC:80292-101-0340 in 1 BOX; Type 0: Not a Combination Product03/30/2020
4NDC:80292-101-0450 in 1 BOX; Type 0: Not a Combination Product03/30/2020
5NDC:80292-101-0560 in 1 BOX; Type 0: Not a Combination Product03/30/2020
6NDC:80292-101-0680 in 1 BOX; 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 - Guangzhou Guangsan Biopharma Co., Ltd. (554538823)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Guangsan Biopharma Co., Ltd.554538823manufacture(80292-101)

Revised: 8/2020
Document Id: adc2ef27-b67b-37f2-e053-2a95a90af7e6
Set id: adc2f006-8bfe-c4bc-e053-2a95a90a4d7d
Version: 1
Effective Time: 20200826
 
Guangzhou Guangsan Biopharma Co., Ltd.