FDA.reportPublic FDA data

American Beauty Advanced Hand Sanitizer

Manufacturer
American Beauty Manufacturing Inc | Enter Establishment Name
Effective date
2020-12-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:01

Label at a glance#

ProductAmerican Beauty Advanced Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Place enough product in your palm to thoroughly cover your hands Rub hands together until dry No rinsing or towels required

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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)

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (65%, 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. Hydroxypropyl Cellulose (1.00% w/w).
  4. Aplha-Tocopherol Acetate (0.05% w/w).
  5. Isopropyl Myristate (0.50% v/v)
  6. 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 65% 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.

Recommended for repeated use

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes.

In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin.

Stop use and ask a doctor if irritation or redness develop.

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 in your palm to thoroughly cover your hands
  • Rub hands together until dry
  • No rinsing or towels required

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, hydroxypropylcellulos, isopropyl myristate, tocopheryl acetate

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.

OTC - QUESTIONS SECTION

Call 918-516-8340 Monday to Friday 8:00am to 5:00pm CST

contact@americanbeautymfg.com

OTHER SAFETY INFORMATION

Do not store above 110*F (43*C)

May discolor certain fabrics or surfaces

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3.78L NDC: 76907-401-01

3.78L Label3.78L Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76907-401-012022-01-28C16284748780-1d6a99b39-8194-a426-e053-dadaa90af4c2b788cfa9-5121-6fd1-e053-2a95a90a42ac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76907-401-01American Beauty Advanced Hand Sanitizer3785 mL in 1 BOTTLE, DISPENSINGGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76907-401AMERICAN BEAUTY ADVANCED HAND SANITIZER (ALCOHOL) GEL [AMERICAN BEAUTY MANUFACTURING INC]1Legacy NDC, 1 package rows20201229_b788cfa9-5121-6fd1-e053-2a95a90a42ac.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76907-40176907-401-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERINPDC6A3C0OXIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED2165RE0K14IACT

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
b788dd71-173d-a69a-e053-2995a90a85bab788cfa9-5121-6fd1-e053-2a95a90a42ac2020-12-28WarningsExact identifier
spl id: b788dd71-173d-a69a-e053-2995a90a85ba
spl set id: b788cfa9-5121-6fd1-e053-2a95a90a42ac

Reported adverse events (FAERS/openFDA)#

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