FDA.reportPublic FDA data

ALTAIO Hand Sanitizing Gel

Manufacturer
BIONATEO SP Z O O
Effective date
2020-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:07

Label at a glance#

ProductALTAIO Hand Sanitizing Gel
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

The ALTAIO Hand Sanitizing Gel is manufactured using the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):

  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. Glycerin (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer 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

  • on 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

50 mL NDC: 78571-002-01

ALTAIO Hand Sanitizing Gel 50 mLALTAIO Hand Sanitizing Gel 50 mL

100 mL NDC: 78571-002-02

ALTAIO Hand Sanitizing Gel 100 mLALTAIO Hand Sanitizing Gel 100 mL

500 mL NDC: 78571-002-03

ALTAIO Hand Sanitizing Gel 500 mLALTAIO Hand Sanitizing Gel 500 mL

1000 mL NDC: 78571-002-04

ALTAIO Hand Sanitizing Gel 1000 mLALTAIO Hand Sanitizing Gel 1000 mL

5000 mL NDC: 78571-002-05

ALTAIO Hand Sanitizing Gel 5000 mLALTAIO Hand Sanitizing Gel 5000 mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78571-002-012022-01-28C16284748780-1d6a99b39-c3aa-a426-e053-dadaa90af4c2a8e36f60-c9c3-08ea-e053-2a95a90a5f56
78571-002-022022-01-28C16284748780-1d6a99b39-c3aa-a426-e053-dadaa90af4c2a8e36f60-c9c3-08ea-e053-2a95a90a5f56
78571-002-032022-01-28C16284748780-1d6a99b39-c3aa-a426-e053-dadaa90af4c2a8e36f60-c9c3-08ea-e053-2a95a90a5f56
78571-002-042022-01-28C16284748780-1d6a99b39-c3aa-a426-e053-dadaa90af4c2a8e36f60-c9c3-08ea-e053-2a95a90a5f56
78571-002-052022-01-28C16284748780-1d6a99b39-c3aa-a426-e053-dadaa90af4c2a8e36f60-c9c3-08ea-e053-2a95a90a5f56

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78571-002-01ALTAIO Hand Sanitizing Gel50 mL in 1 BOTTLE, PLASTICLIQUID501
78571-002-02ALTAIO Hand Sanitizing Gel100 mL in 1 BOTTLE, PLASTICLIQUID1001
78571-002-03ALTAIO Hand Sanitizing Gel500 mL in 1 BOTTLE, PUMPLIQUID5001
78571-002-04ALTAIO Hand Sanitizing Gel1000 mL in 1 BOTTLE, PUMPLIQUID10001
78571-002-05ALTAIO Hand Sanitizing Gel5000 mL in 1 BOTTLE, PLASTICLIQUID50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78571-002ALTAIO HAND SANITIZING GEL (ALCOHOL) LIQUID [BIONATEO SP Z O O]1Legacy NDC, 5 package rows20200626_a8e36f60-c9c3-08ea-e053-2a95a90a5f56.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
78571-00278571-002-01, 78571-002-02, 78571-002-03, 78571-002-04, 78571-002-05

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
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a8e37401-a4fb-680a-e053-2a95a90a298ca8e36f60-c9c3-08ea-e053-2a95a90a5f562020-06-25WarningsExact identifier
spl id: a8e37401-a4fb-680a-e053-2a95a90a298c
spl set id: a8e36f60-c9c3-08ea-e053-2a95a90a5f56

Reported adverse events (FAERS/openFDA)#

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