ALCOHOL WIPES- alcohol wipes cloth 
Tianjin Shurou Sanitary Products 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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ALCOHOL WIPES

This is a hand sanitizer 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 hand sanitizer 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. Isopropyl Alcohol (75%, 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.

Active Ingredient(s)

Alcohol 70%v/v Purpose: Antiseptic

Purpose

Antiseptic

Use

Alcohol Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
For external use only. Flammable. Keep away from heat or flame.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

in children less than 6 years of age.
on open skin wounds.

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

Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

Parfum, purified water, spunlace nonwoven

Package Label - Principal Display Panel

1

ALCOHOL WIPES 
alcohol wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76969-006
Route of AdministrationTOPICAL, CUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76969-006-01100 g 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 - Tianjin Shurou Sanitary Products Co., Ltd (554531083)
Establishment
NameAddressID/FEIBusiness Operations
Tianjin Shurou Sanitary Products Co., Ltd554531083manufacture(76969-006)

Revised: 5/2020
Document Id: a599b870-9273-542e-e053-2995a90af7c2
Set id: a599b870-9281-542e-e053-2995a90af7c2
Version: 1
Effective Time: 20200514
 
Tianjin Shurou Sanitary Products Co., Ltd