75% ALCOHOL WIPES- disinfection wet wipes patch 
Zhuji Jianhe Paper 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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JianHe, 75% Alcohol Wipes, *10

Active ingredient

Ethanol Alcohol, 75% v/v, antiseptic

Inactive ingredient

Water

Purpose

Daily Clean for daily items and Antimicrobial.

When using

This product is used to wipe hands, faces, skins, etc. It can also be used to clean many kinds of places.

Do not use

Stop use

if irritation or rash occurs.

These may be signs of a serious condition.

Keep out of reach of children

Keep out of reach of children.

Indications & usage

This product is used to wipe hands, faces, skins, etc. It can also be used to clean many kinds of places.

Open the label, take out the wet towel and wipe the target area.

Dosage & administration

Use it as needed, after following the usage instructions.

For external use only.

Warnings

Do not apply this product to red and swollen skin, wound or any part sensitive to it.

Keep this product out of children’s reach in case they might eat it.
Alcohol is violatile, please use it as soon as possible after opening, store it in a cool and dry place, avoid direct sunlight and open fire, and avoid contact with eyes and damaged skin.

Package label. Principal display panel

88

75% ALCOHOL WIPES 
disinfection wet wipes patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75163-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 U  in 1 U
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75163-100-1010 U in 1 PACKAGE; Type 0: Not a Combination Product04/21/2020
2NDC:75163-100-011 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
3NDC:75163-100-1220 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
4NDC:75163-100-1430 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
5NDC:75163-100-1640 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
6NDC:75163-100-2050 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
7NDC:75163-100-2260 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
8NDC:75163-100-2680 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
9NDC:75163-100-30100 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
10NDC:75163-100-36160 U in 1 PACKAGE; Type 0: Not a Combination Product05/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/21/2020
Labeler - Zhuji Jianhe Paper Co., Ltd (554529241)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
Zhuji Jianhe Paper Co., Ltd554529241label(75163-100) , manufacture(75163-100)

Revised: 5/2020
Document Id: a602d87a-830c-b4bf-e053-2a95a90a51a1
Set id: a3d9ed86-6008-27c9-e053-2a95a90ad6e9
Version: 2
Effective Time: 20200519
 
Zhuji Jianhe Paper Co., Ltd