FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
ALFA VITAMINS LABORATORIES INC
Effective date
2020-09-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:32:00

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Place enough product in your to thoroughly covere hands Rub hands together briskly until mdry Children under 6 years of age should be supervised when using the product

Storage and handling

Store below 110F (43C) May discolor certain fabrics or surfaces

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. 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 70% v/v. Purpose: Antiseptic

Active IngredientsActive Ingredients

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

PurposePurpose

DIRECTIONS

INDICATIONS & USAGE SECTION

Place enough product in your to thoroughly covere hands

Rub hands together briskly until mdry

Children under 6 years of age should be supervised when using the product

DirectionsDirections

Warnings

WARNINGS SECTION

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

WarningsWarnings

Do not use

OTC - DO NOT USE SECTION

  • Do not get into eyes
  • If contact occurs, rinse eyes throughly with water

Do Not UseDo Not Use

OTC - WHEN USING SECTION

Do not get into eyes

If contact occurs, rinse eyes throughly with water

WHEN IN USEWHEN IN USE

OTC - STOP USE SECTION

Irritation or rash appears and lasts

STOP USE SECTIONSTOP USE SECTION

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.

KEEP OUT OF REACH OF CHILDRENKEEP OUT OF REACH OF CHILDREN

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover hands
  • Rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product

DIRECTIONS OF USEDIRECTIONS OF USE

Other information

STORAGE AND HANDLING SECTION

  • Store below 110F (43C)
  • May discolor certain fabrics or surfaces

OTHER INFORMATIONOTHER INFORMATION

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera, Carbomer, Fragrance, Glycerin, Methyl Gluceth-20, Purief Water, Propylene Glycol, Triethanolamine

INACTIVE INGREDIENTSINACTIVE INGREDIENTS

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

472 mL NDC: 13298-156-16

FRONT PANELFRONT PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13298-156-042022-01-28C16284748780-1d6a99b39-e411-a426-e053-dadaa90af4c2aee31013-ae2f-c623-e053-2995a90a22dc
13298-156-162022-01-28C16284748780-1d6a99b39-e411-a426-e053-dadaa90af4c2aee31013-ae2f-c623-e053-2995a90a22dc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13298-156-04Hand Sanitizer118 mL in 1 BOTTLEJELLY1182
13298-156-16Hand Sanitizer472 mL in 1 BOTTLEJELLY4722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13298-156HAND SANITIZER (ALCOHOL) JELLY [ALFA VITAMINS LABORATORIES INC]2Legacy NDC, 2 package rows20201020_aee31013-ae2f-c623-e053-2995a90a22dc.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13298-15613298-156-04, 13298-156-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
METHYL GLUCETH-20J3QD0LD11PIACT
CARBOMER 9404Q93RCW27EIACT
FRAGRANCE CLEAN ORC0600327329LCV5BTFIACT
ALOE VERA WHOLEKIZ4X2EHYXIACT
TRIETHANOLAMINE DODECYLBENZENESULFONATE8HM7ZD48HNIACT

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
aee31013-ae21-c623-e053-2995a90a22dcaee31013-ae2f-c623-e053-2995a90a22dc2020-09-23WarningsExact identifier
spl id: aee31013-ae21-c623-e053-2995a90a22dc
spl set id: aee31013-ae2f-c623-e053-2995a90a22dc

Reported adverse events (FAERS/openFDA)#

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