FDA.reportPublic FDA data

Biomate Multi-Purpose Alcohol Wipes

Manufacturer
KYB KUYUMCULUK INSAAT TURIZM GIDA ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI
Effective date
2020-10-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:09

Label at a glance#

ProductBiomate Multi-Purpose Alcohol Wipes
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Multi-purpose alcohol wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

192 ml label NDC:80560-002-01192 ml label NDC:80560-002-01

192 ml NDC 80560-002-01

240 ml cannister label NDC:80560-002-03240 ml cannister label NDC:80560-002-03

240 ml NDC 80560-002-03

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

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

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

960 ml NDC: 80560-002-07960 ml NDC: 80560-002-07480 ml NDC: 80560-002-07

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80560-002-012022-01-28C16284748780-1d6a99b39-e46e-a426-e053-dadaa90af4c2b21d7933-3eea-fb30-e053-2995a90add14
80560-002-022022-01-28C16284748780-1d6a99b39-e46e-a426-e053-dadaa90af4c2b21d7933-3eea-fb30-e053-2995a90add14
80560-002-032022-01-28C16284748780-1d6a99b39-e46e-a426-e053-dadaa90af4c2b21d7933-3eea-fb30-e053-2995a90add14
80560-002-042022-01-28C16284748780-1d6a99b39-e46e-a426-e053-dadaa90af4c2b21d7933-3eea-fb30-e053-2995a90add14
80560-002-052022-01-28C16284748780-1d6a99b39-e46e-a426-e053-dadaa90af4c2b21d7933-3eea-fb30-e053-2995a90add14
80560-002-062022-01-28C16284748780-1d6a99b39-e46e-a426-e053-dadaa90af4c2b21d7933-3eea-fb30-e053-2995a90add14
80560-002-072022-01-28C16284748780-1d6a99b39-e46e-a426-e053-dadaa90af4c2b21d7933-3eea-fb30-e053-2995a90add14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80560-002-01Biomate Multi-Purpose Alcohol Wipes192 mL in 1 CANISTERCELLULAR SHEET1921
80560-002-02Biomate Multi-Purpose Alcohol Wipes175 mL in 1 PACKAGECELLULAR SHEET1751
80560-002-03Biomate Multi-Purpose Alcohol Wipes240 mL in 1 CANISTERCELLULAR SHEET2401
80560-002-04Biomate Multi-Purpose Alcohol Wipes360 mL in 1 CANISTERCELLULAR SHEET3601
80560-002-05Biomate Multi-Purpose Alcohol Wipes384 mL in 1 CANISTERCELLULAR SHEET3841
80560-002-06Biomate Multi-Purpose Alcohol Wipes480 mL in 1 CANISTERCELLULAR SHEET4801
80560-002-07Biomate Multi-Purpose Alcohol Wipes960 mL in 1 CANISTERCELLULAR SHEET9601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80560-002BIOMATE MULTI-PURPOSE ALCOHOL WIPES (ALCOHOL) CELLULAR SHEET [KYB KUYUMCULUK INSAAT TURIZM GIDA ITHALAT IHRACAT SANAYI VE TICARET LIMITED SIRKETI]1Legacy NDC, 7 package rows20201021_b21d7933-3eea-fb30-e053-2995a90add14.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80560-00280560-002-01, 80560-002-02, 80560-002-03, 80560-002-04, 80560-002-05, 80560-002-06, 80560-002-07

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b218eb2d-2e1f-2ce5-e053-2995a90a1f10b21d7933-3eea-fb30-e053-2995a90add142020-10-20WarningsExact identifier
spl id: b218eb2d-2e1f-2ce5-e053-2995a90a1f10
spl set id: b21d7933-3eea-fb30-e053-2995a90add14

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.