hand sanitizer

Manufacturer
Heritage Hemp LLC
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:52

Label at a glance#

Producthand sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wet all surfaces of hands with product. Rub hands together until dry. Supervise children under 6 years old using this product to prevent swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and 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.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Drug facts labelDrug facts label

Purpose

OTC - PURPOSE SECTION

Antiseptic

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

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash develop or lasts for more than 72 hours.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet all surfaces of hands with product. Rub hands together until dry.
  • Supervise children under 6 years old using this product to prevent swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP, essential oils

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

66 mL NDC: 74853-043-01

2.2 oz2.2 oz

3.78 L NDC: 74853-043-02

1 Gallon1 Gallon

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN3
1039339ethanol 0.8 ML/ML Topical SolutionSCD3
1039339ethanol 80 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74853-043-042023-07-28C16284748780-10191ceaa-6777-198a-e063-dbdaa90aec3eHand sanitizer
74853-043-052023-07-28C16284748780-10191ceaa-6777-198a-e063-dbdaa90aec3eHand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74853-043-04hand sanitizer3780 mL in 1 JUGLIQUID37803
74853-043-05hand sanitizer66 mL in 1 BOTTLE, SPRAYLIQUID663

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74853-043HAND SANITIZER (ALCOHOL) LIQUID [HERITAGE HEMP LLC]3Legacy NDC, 2 package rows20220114_d578c3c8-8164-567b-e053-2a95a90aa809.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74853-04374853-043-05, 74853-043-04

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
d5788aa2-1c13-5e54-e053-2995a90a6743d578c3c8-8164-567b-e053-2a95a90aa8092022-01-13WarningsExact identifier
spl id: d5788aa2-1c13-5e54-e053-2995a90a6743
spl set id: d578c3c8-8164-567b-e053-2a95a90aa809

Reported adverse events (FAERS/openFDA)#

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