Hand Sanitizer

Manufacturer
All Clean Natural Ltd.
Effective date
2020-10-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:31:21

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Children 2 - 11 years • Adolescents 12 - 17 years • Adults 18 years and older: Supervise children when they use this product. For occasional and personal domestic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

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. 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.

MEDICINAL INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol, USP 80% v/v

CAUTIONS AND WARNINGS:

WARNINGS SECTION

Flammability warning: Keep away from open flame and sources of heat. For external use only. Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

Contraindications:

OTC - DO NOT USE SECTION

Do not use on children/infants less than 2 years of age (unless directed by a doctor/physician/ health care practitioner/ health care provider/ health care professional.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops.

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

Children 2 - 11 years • Adolescents 12 - 17 years • Adults 18 years and older: Supervise children when they use this product. For occasional and personal domestic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

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, hydrogen peroxide, purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

270 Wipes270 Wipes

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2361646ethanol 80 % Medicated PadPSN2
2361646ethanol 0.8 ML/ML Medicated PadSCD2
2361646ethanol 80 % Medicated WipesSY2
2361646ethyl alcohol 80 % Topical ClothSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78806-500-402022-01-28C16284748780-1d6a99b39-fd9e-a426-e053-dadaa90af4c2Checkers Sanitizing Wipes
78806-500-502022-01-28C16284748780-1d6a99b39-fd9e-a426-e053-dadaa90af4c2Checkers Sanitizing Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78806-500-40Hand Sanitizer270 in 1 CANISTERCLOTH2702
78806-500-40Hand Sanitizer5 mL in 1 PACKAGECLOTH52
78806-500-50Hand Sanitizer450 in 1 CANISTERCLOTH4502
78806-500-50Hand Sanitizer5 mL in 1 PACKAGECLOTH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78806-500HAND SANITIZER (ETHYL ALCOHOL) CLOTH [ALL CLEAN NATURAL LTD.]2Legacy NDC, 4 package rows20201010_acd7a12f-a70d-7c36-e053-2a95a90a373c.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
78806-50078806-500-40, 78806-500-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
b143d7f2-ba87-9e07-e053-2a95a90a7beaacd7a12f-a70d-7c36-e053-2a95a90a373c2020-10-09WarningsExact identifier
spl id: b143d7f2-ba87-9e07-e053-2a95a90a7bea
spl set id: acd7a12f-a70d-7c36-e053-2a95a90a373c

Reported adverse events (FAERS/openFDA)#

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