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 structure12 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.

Active ingredient & Purpose

OTC - ACTIVE INGREDIENT SECTION

Antiseptic, Hand Sanitizer

OTC - PURPOSE SECTION

Active ingredientPurpose
Alcohol 75% 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, trolamine, betaine, carbomer homopolymer, purified water USP

Packaging Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1.9L ml NDC: 74895-103-09

1.9L Bottle Label1.9L Bottle Label

473 ml NDC: 74895-103-08

473ML Bottle Label473ML Bottle Label

295 ml NDC: 74895-103-07

295 Bottle Label295 Bottle Label

59 ml NDC: 74895-103-06

59ml Bottle Label59ml Bottle Label

80 mL NDC: 74895-103-01 80 mL Bottle Label80 mL Bottle Label

480 mL NDC: 74895-103-02 480 mL Bottle Label480 mL Bottle Label

290 mL NDC: 74895-103-03 290 mL Bottle Label290 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN4
1305100ethanol 0.75 ML/ML Topical GelSCD4
1305100ethanol 75 % Topical GelSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74895-103-01Hand Sanitizer80 mL in 1 TUBEGEL804
74895-103-02Hand Sanitizer480 mL in 1 BOTTLE, PUMPGEL4804
74895-103-03Hand Sanitizer290 mL in 1 BOTTLE, PUMPGEL2904
74895-103-04Hand Sanitizer236 mL in 1 BOTTLE, PUMPGEL2364
74895-103-05Hand Sanitizer60 mL in 1 BOTTLE, PUMPGEL604
74895-103-06Hand Sanitizer59 mL in 1 BOTTLEGEL594
74895-103-07Hand Sanitizer295 mL in 1 BOTTLE, PUMPGEL2954
74895-103-08Hand Sanitizer473 mL in 1 BOTTLE, PUMPGEL4734
74895-103-09Hand Sanitizer1900 mL in 1 BOTTLE, PUMPGEL19004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74895-103HAND SANITIZER GEL [GUANGDONG HAOSHUN ODIS TECHNOLOGY COMPANY LIMITED]4Legacy NDC, 9 package rows20210112_a745b3fd-8ded-9d48-e053-2995a90ab7f4.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
b8a383ba-dd19-e5a4-e053-2995a90ae6e5a745b3fd-8ded-9d48-e053-2995a90ab7f42021-01-11WarningsExact identifier
spl id: b8a383ba-dd19-e5a4-e053-2995a90ae6e5
spl set id: a745b3fd-8ded-9d48-e053-2995a90ab7f4

Reported adverse events (FAERS/openFDA)#

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