Hand Sanitizer Gel 73% Alcohol Antiseptic

Manufacturer
Solugen Blending LLC
Effective date
2020-09-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:20

Label at a glance#

ProductHand Sanitizer Gel 73% Alcohol Antiseptic
Active ingredientALCOHOL
Label structure13 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#

Hand Sanitizer Gel 73% Alcohol Antiseptic

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the part333A of the OTC monograph.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage formulation)

a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (73%, volume/volume (v/v) in an aqueos solution denatured according to Alcohol and Tobacco Bureau regulations in 27 CFR part 20.

b. Glycerol (1.15% v/v).

c. Hydroxymethyl Cellulose (1.00% v/v).

d. Sterile distilled water or boiled cold water.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 73% 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

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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • 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, methyl cellulose, purified water USP

Hand Sanitizer Gel 73% Alcohol Antiseptic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

18927000 ml label NDC 79975-008-0118927000 ml label NDC 79975-008-0118927000 mL NDC: 79975-008-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2286987ethanol 73 % Topical GelPSN1
2286987ethanol 0.73 ML/ML Topical GelSCD1
2286987ethanol 73 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79975-008-01Hand Sanitizer Gel 73% Alcohol Antiseptic18927000 mL in 1 TANKGEL189270001
79975-008-02Hand Sanitizer Gel 73% Alcohol Antiseptic1249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL12490001
79975-008-03Hand Sanitizer Gel 73% Alcohol Antiseptic208198 mL in 1 DRUMGEL2081981
79975-008-04Hand Sanitizer Gel 73% Alcohol Antiseptic18927 mL in 1 DRUMGEL189271
79975-008-05Hand Sanitizer Gel 73% Alcohol Antiseptic3785 mL in 1 PAILGEL37851
79975-008-09Hand Sanitizer Gel 73% Alcohol Antiseptic1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79975-008HAND SANITIZER GEL 73% ALCOHOL ANTISEPTIC (ALCOHOL) GEL [SOLUGEN BLENDING LLC]1Legacy NDC, 6 package rows20200915_af491c1f-6e69-5364-e053-2a95a90a6f66.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
79975-00879975-008-01, 79975-008-02, 79975-008-03, 79975-008-04, 79975-008-05, 79975-008-09

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
af491c1f-6e5b-5364-e053-2a95a90a6f66af491c1f-6e69-5364-e053-2a95a90a6f662020-09-11WarningsExact identifier
spl id: af491c1f-6e5b-5364-e053-2a95a90a6f66
spl set id: af491c1f-6e69-5364-e053-2a95a90a6f66

Reported adverse events (FAERS/openFDA)#

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