BIOMATE MULTI-PURPOSE ALCOHOL WIPES- alcohol cellular sheet 
KYB KUYUMCULUK INSAAT TURIZM GIDA ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI

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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This is a multi-purpose alcohol wipes 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 multi-purpose alcohol wipes 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) (80%, 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.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Multi-purpose 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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

175 ml package label NDC: 80560-002-02175 ml NDC 80560-002-02

192 ml label NDC:80560-002-01

192 ml NDC 80560-002-01

240 ml cannister label NDC:80560-002-03

240 ml NDC 80560-002-03

360 ml  label NDC: 80560-002-04360 ml NDC: 80560-002-04

384 ml NDC: 80560-002-05384 ml NDC: 80560-002-05

480 ml NDC: 80560-002-06480 ml NDC: 80560-002-06

960 ml NDC: 80560-002-07480 ml NDC: 80560-002-07

BIOMATE MULTI-PURPOSE ALCOHOL WIPES 
alcohol cellular sheet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80560-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80560-002-01192 mL in 1 CANISTER; Type 0: Not a Combination Product08/06/2020
2NDC:80560-002-02175 mL in 1 PACKAGE; Type 0: Not a Combination Product08/06/2020
3NDC:80560-002-03240 mL in 1 CANISTER; Type 0: Not a Combination Product08/06/2020
4NDC:80560-002-04360 mL in 1 CANISTER; Type 0: Not a Combination Product08/06/2020
5NDC:80560-002-05384 mL in 1 CANISTER; Type 0: Not a Combination Product08/06/2020
6NDC:80560-002-06480 mL in 1 CANISTER; Type 0: Not a Combination Product08/06/2020
7NDC:80560-002-07960 mL in 1 CANISTER; Type 0: Not a Combination Product08/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/06/2020
Labeler - KYB KUYUMCULUK INSAAT TURIZM GIDA ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI (365680187)
Establishment
NameAddressID/FEIBusiness Operations
KYB KUYUMCULUK INSAAT TURIZM GIDA ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI365680187manufacture(80560-002)

Revised: 10/2020
Document Id: b218eb2d-2e1f-2ce5-e053-2995a90a1f10
Set id: b21d7933-3eea-fb30-e053-2995a90add14
Version: 1
Effective Time: 20201020
 
KYB KUYUMCULUK INSAAT TURIZM GIDA ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI