a821f647-be63-274c-e053-2a95a90a23ce

SPL v1
SPL
SPL Set ID a821f647-be63-274c-e053-2a95a90a23ce
Route
topical
Published
Effective Date 2020-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
chloroxylenol glycerin methyl gluceth-10 water aminomethylpropanol carbomer interpolymer type a (55000 cps)

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-07-15
Purpose

Antiseptic

Description

Ethanol 75%v/v

Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame.

Purpose

Antiseptic

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under age 6 when using this product avoid swallowing.
Other Information
  • Store between 15-30°C (59-86F).
  • Avoid freezing and excessive heat above 40°C (104F).
Inactive Ingredients

Acrylates/c10-30 alkyl acrylate crosspolymer, aminomethyl propanol, chloroxylenol, glycerin, methyl gluceth-10, parfum, water.

Description

Ethanol 75%v/v

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Do Not Use
  • on children less than 2 months of age
  • on open skin wounds
Active Ingredient

Ethanol 75%v/v

When Using This Product;

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

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.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Package Label/principal Display Panel

NDC: 78692-134-34; 500 ml

Structured Label Content

Warnings

For external use only. Flammable. Keep away from heat or flame.

Purpose

Antiseptic

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under age 6 when using this product avoid swallowing.
Other Information (Other information)
  • Store between 15-30°C (59-86F).
  • Avoid freezing and excessive heat above 40°C (104F).
Inactive Ingredients (Inactive ingredients)

Acrylates/c10-30 alkyl acrylate crosspolymer, aminomethyl propanol, chloroxylenol, glycerin, methyl gluceth-10, parfum, water.

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Do Not Use (Do not use)
  • on children less than 2 months of age
  • on open skin wounds
Active Ingredient

Ethanol 75%v/v

When Using This Product; (When using this product;)

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 (Stop use and ask a doctor)

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. (Keep out of reach of children.)

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Package Label/principal Display Panel (Package Label/Principal Display Panel)

NDC: 78692-134-34; 500 ml

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:11.899769 · Updated: 2026-03-14T22:57:38.360001