FDA.reportPublic FDA data

Ame Hand Sanitizer

Manufacturer
DR.AMERICO GROUP JOINT STOCK COMPANY
Effective date
2020-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:35:01

Label at a glance#

ProductAme Hand Sanitizer
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 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. 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. 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

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

  • 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, purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

378537852502501001005000500010001000500500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130784099831935GTIN-13: 0784099831935
EAN-13: 0784099831935
GTIN-12: 784099831935
UPC-A: 784099831935
GTIN storage (14 digits): 00784099831935		HS100.jpg
BarcodeEAN-130784099831959GTIN-13: 0784099831959
EAN-13: 0784099831959
GTIN-12: 784099831959
UPC-A: 784099831959
GTIN storage (14 digits): 00784099831959		HS500.jpg
BarcodeEAN-130784099831966GTIN-13: 0784099831966
EAN-13: 0784099831966
GTIN-12: 784099831966
UPC-A: 784099831966
GTIN storage (14 digits): 00784099831966		HS1000.jpg
BarcodeEAN-130784099831973GTIN-13: 0784099831973
EAN-13: 0784099831973
GTIN-12: 784099831973
UPC-A: 784099831973
GTIN storage (14 digits): 00784099831973		HS3785.jpg
BarcodeEAN-130784099831980GTIN-13: 0784099831980
EAN-13: 0784099831980
GTIN-12: 784099831980
UPC-A: 784099831980
GTIN storage (14 digits): 00784099831980		HS5000.jpg
Data codeQR CodeAME HAND SANITIZER SOLUTION PRODUCT OF DR. AMERICO GROUP JOINT STOCK COMPANY Web: www.dramericofactory.com A BRAND OF DR. AMERICO GROUP LLC.HS500.jpg, HS5000.jpg, HS3785.jpg, HS100.jpg, HS1000.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80870-801-012022-01-28C16284748780-1d6a99b39-e7c9-a426-e053-dadaa90af4c2b2322b28-42aa-18c3-e053-2a95a90a2256
80870-801-022022-01-28C16284748780-1d6a99b39-e7c9-a426-e053-dadaa90af4c2b2322b28-42aa-18c3-e053-2a95a90a2256
80870-801-032022-01-28C16284748780-1d6a99b39-e7c9-a426-e053-dadaa90af4c2b2322b28-42aa-18c3-e053-2a95a90a2256
80870-801-042022-01-28C16284748780-1d6a99b39-e7c9-a426-e053-dadaa90af4c2b2322b28-42aa-18c3-e053-2a95a90a2256
80870-801-052022-01-28C16284748780-1d6a99b39-e7c9-a426-e053-dadaa90af4c2b2322b28-42aa-18c3-e053-2a95a90a2256
80870-801-062022-01-28C16284748780-1d6a99b39-e7c9-a426-e053-dadaa90af4c2b2322b28-42aa-18c3-e053-2a95a90a2256

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80870-801-01Ame Hand Sanitizer100 mL in 1 BOTTLELIQUID1002
80870-801-02Ame Hand Sanitizer250 mL in 1 BOTTLELIQUID2502
80870-801-03Ame Hand Sanitizer500 mL in 1 BOTTLELIQUID5002
80870-801-04Ame Hand Sanitizer1000 mL in 1 BOTTLELIQUID10002
80870-801-05Ame Hand Sanitizer3785.4 mL in 1 BOTTLELIQUID3785.42
80870-801-06Ame Hand Sanitizer5000 mL in 1 BOTTLELIQUID50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80870-801AME HAND SANITIZER (HAND SANITIZER) LIQUID [DR.AMERICO GROUP JOINT STOCK COMPANY]2Legacy NDC, 6 package rows20201211_b2322b28-42aa-18c3-e053-2a95a90a2256.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
80870-80180870-801-01, 80870-801-03, 80870-801-05, 80870-801-04, 80870-801-06, 80870-801-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
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
b5b624ca-0b3f-791f-e053-2a95a90a9a50b2322b28-42aa-18c3-e053-2a95a90a22562020-12-05WarningsExact identifier
spl id: b5b624ca-0b3f-791f-e053-2a95a90a9a50
spl set id: b2322b28-42aa-18c3-e053-2a95a90a2256

Reported adverse events (FAERS/openFDA)#

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