FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
CARE + 1 LLC
Effective date
2020-12-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:18

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Open lid, pull back reseable label, remove a wipe for use. Reseal back after use to avoid evaporation of alcohol

Storage and handling

Store between 15-30C (59-86F) Dispose of wipes in the proper container Do not flush down the toilet

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% 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

OTC - WHEN USING SECTION

When using this product

Avoid contact with eyes. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts

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

  • Open lid, pull back reseable label, remove a wipe for use.
  • Reseal back after use to avoid evaporation of alcohol

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Dispose of wipes in the proper container
  • Do not flush down the toilet

Inactive ingredients

INACTIVE INGREDIENT SECTION

water (aqua), glycerin, Aloe arbadensis leaf extract (Alove Vera), Tocopheryl acetate (Vitamin E)

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:

Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerol (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand Sanitizer WipesHand Sanitizer WipesNDC: 80072-002-10

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1307051ethanol 75 % Medicated PadPSN1
1307051ethanol 0.75 ML/ML Medicated PadSCD1
1307051ethanol 75 % Hand Sanitizer WipesSY1
1307051ethyl alcohol 75 % Topical ClothSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80072-002-102022-01-28C16284748780-1d6a99b39-80ea-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80072-002-10Hand Sanitizer10 mL in 1 BAGCLOTH101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80072-002HAND SANITIZER (ALCOHOL) CLOTH [CARE + 1 LLC]1Legacy NDC, 1 package rows20201216_b676ac2a-fbf3-ae77-e053-2a95a90a278c.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80072-00280072-002-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT

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
b676a6cb-0a47-d4d4-e053-2a95a90aa613b676ac2a-fbf3-ae77-e053-2a95a90a278c2020-12-14WarningsExact identifier
spl id: b676a6cb-0a47-d4d4-e053-2a95a90aa613
spl set id: b676ac2a-fbf3-ae77-e053-2a95a90a278c

Reported adverse events (FAERS/openFDA)#

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