Hand Sanitizer

Manufacturer
GUANGDONG HAOSHUN ODIS TECHNOLOGY COMPANY LIMITED
Effective date
2021-01-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:36:45

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

place enough product on hands to cover all surfaces. Rub hands together until dry. supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

store between 15-30C (59-86F) avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

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 & Purpose

OTC - ACTIVE INGREDIENT SECTION

Antiseptic, Hand Sanitizer

OTC - PURPOSE SECTION

Active ingredientPurpose
Alcohol 80% v/v ..............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

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • place enough product on hands to cover all surfaces. Rub hands together until dry.
  • supervise children under 6 years of age when using this product to avoid swallowing.

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 USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

74895-102-02 180 ml bottle label180 ml bottle label

74895-102-03 450 ml bottle label450 ml bottle label

74895-102-04 500 ml bottle label500 ml bottle label

74895-102-05 650 ml bottle label650 ml bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN4
1039339ethanol 0.8 ML/ML Topical SolutionSCD4
1039339ethanol 80 % Topical SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74895-102-02Hand Sanitizer180 mL in 1 BOTTLE, PUMPLIQUID1804
74895-102-03Hand Sanitizer450 mL in 1 BOTTLE, SPRAYLIQUID4504
74895-102-04Hand Sanitizer500 mL in 1 BOTTLE, SPRAYLIQUID5004
74895-102-05Hand Sanitizer650 mL in 1 BOTTLE, SPRAYLIQUID6504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74895-102HAND SANITIZER (ALCOHOL) LIQUID [GUANGDONG HAOSHUN ODIS TECHNOLOGY COMPANY LIMITED]4Legacy NDC, 4 package rows20210112_a2cabf40-150e-5ddf-e053-2995a90a7406.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
74895-10274895-102-02, 74895-102-03, 74895-102-04, 74895-102-05

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 · Source PDF

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
b8a3181d-9901-454f-e053-2995a90a96c0a2cabf40-150e-5ddf-e053-2995a90a74062021-01-11WarningsExact identifier
spl id: b8a3181d-9901-454f-e053-2995a90a96c0
spl set id: a2cabf40-150e-5ddf-e053-2995a90a7406

Reported adverse events (FAERS/openFDA)#

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