Hand Sanitizing Gel

Manufacturer
Alpha Aromatics
Effective date
2020-04-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:20

Label at a glance#

ProductHand Sanitizing Gel
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#

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured in accordance with the recommendations in 21 CFR Part 333 for alcohol based topical antimicrobial OTC products for human use.

  1. Alcohol(Ethanol) 62% (v/v).
  2. Sorbitol 0.6% (v/v).
  3. Gylcerin 0.6% (v/v).
  4. PEG-27 copolymer 0.375% (v/v)
  5. Triethanol 0.7% (v/v)
  6. 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

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, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

203000 mL NDC: 75009-162-01

203000 ml label203000 ml label

868300 mL NDC: 75009-162-02

868300 ml label868300 ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75009-162-012022-01-28C16284748780-1d6a99b39-d80c-a426-e053-dadaa90af4c2Hand Sanitizing Gel 62% (v/v)
75009-162-022022-01-28C16284748780-1d6a99b39-d80c-a426-e053-dadaa90af4c2Hand Sanitizing Gel 62% (v/v)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75009-162-01Hand Sanitizing Gel203000 mL in 1 DRUMGEL2030001
75009-162-02Hand Sanitizing Gel868300 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL8683001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75009-162HAND SANITIZING GEL (ALCOHOL) GEL [ALPHA AROMATICS]1Legacy NDC, 2 package rows20200502_a487a584-619d-5567-e053-2995a90a3c93.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75009-16275009-162-01, 75009-162-02

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 · 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
a4879519-ed52-25b8-e053-2a95a90a4693a487a584-619d-5567-e053-2995a90a3c932020-04-30WarningsExact identifier
spl id: a4879519-ed52-25b8-e053-2a95a90a4693
spl set id: a487a584-619d-5567-e053-2995a90a3c93

Reported adverse events (FAERS/openFDA)#

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