FDA.reportPublic FDA data

Anti-Bacterial Hand Sanitizer Gel

Manufacturer
Webb Business Promotions, Inc
Effective date
2022-01-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:46:20

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Squeeze enough product on hands to cover all surfaces. Rub hands together until dry.

Storage and handling

Store between 20C (68-77F) May discolore fabrics

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) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help decrese bacteria on the skin.

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.

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

  • Squeeze enough product on hands to cover all surfaces. Rub hands together until dry.

Other information

STORAGE AND HANDLING SECTION

  • Store between 20C (68-77F)
  • May discolore fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Carbomer, Tocopherol, Aloe Vera

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75% Hand Sanitizer75% Hand Sanitizer240 mL NDC: 70445-414-18

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN8
1305100ethanol 0.75 ML/ML Topical GelSCD8
1305100ethanol 75 % Topical GelSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70445-414-162023-07-28C16284748780-10191ceaa-727e-198a-e063-dbdaa90aec3eAnti-Bacterial Hand Sanitizer Gel
70445-414-182023-07-28C16284748780-10191ceaa-727e-198a-e063-dbdaa90aec3eAnti-Bacterial Hand Sanitizer Gel
70445-414-372023-07-28C16284748780-10191ceaa-727e-198a-e063-dbdaa90aec3eAnti-Bacterial Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70445-414-16Hand Sanitizer480 mL in 1 BOTTLEGEL4808
70445-414-18Hand Sanitizer240 mL in 1 BOTTLEGEL2408
70445-414-37Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICGEL37858

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70445-414HAND SANITIZER (ALCOHOL) GEL [WEBB BUSINESS PROMOTIONS, INC]8Legacy NDC, 3 package rows20220105_aef6cc72-ee8e-ec28-e053-2995a90a04f2.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
70445-41470445-414-37, 70445-414-18, 70445-414-16

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
TOCOPHEROLR0ZB2556P8IACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT

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
d4c72c78-7d9a-4a4a-e053-2995a90ac9acaef6cc72-ee8e-ec28-e053-2995a90a04f22022-01-04WarningsExact identifier
spl id: d4c72c78-7d9a-4a4a-e053-2995a90ac9ac
spl set id: aef6cc72-ee8e-ec28-e053-2995a90a04f2

Reported adverse events (FAERS/openFDA)#

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