SPL v1
SPL
SPL Set ID ec369a4c-ded9-4660-b214-8d55ccd7d670
Route
TOPICAL
Published
Effective Date 2020-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Trolamine Glycerin Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-18
Description

Alcohol 62% v/v

Purpose

 Antiseptic

Medication Information

Purpose

 Antiseptic

Dosage and Administration
  • Squeeze 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.
Description

Alcohol 62% v/v

use
  • hand sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.
Section 50565-1

In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Warning

For external use only

Flammable, keep away from fire or flame.

When using this product

  • keep out of eyes, ears, and mouth.
  • In case of eye contact immediately flush eyes thoroughly with water.

Stop use and ask a doctor if

  • irritation or redness develops
  • conditions persist for more than 75 hours.

Other Information:

  • Store between 15-30 ℃ (59-86℉)
  • may discolor fabrics or surfaces
Packaging

Active Ingredient

Alcohol 62% v/v

Inactive Ingredients

Water, Carbomer, Aminomethyl Propanol

Structured Label Content

use (Use)
  • hand sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.
Dosage and Administration (34068-7)
  • Squeeze 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.
Section 50565-1 (50565-1)

In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Purpose

 Antiseptic

Warning

For external use only

Flammable, keep away from fire or flame.

When using this product

  • keep out of eyes, ears, and mouth.
  • In case of eye contact immediately flush eyes thoroughly with water.

Stop use and ask a doctor if

  • irritation or redness develops
  • conditions persist for more than 75 hours.

Other Information:

  • Store between 15-30 ℃ (59-86℉)
  • may discolor fabrics or surfaces
Packaging

Active Ingredient (Active ingredient)

Alcohol 62% v/v

Inactive Ingredients (Inactive ingredients)

Water, Carbomer, Aminomethyl Propanol

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:37.091047 · Updated: 2026-03-14T22:56:50.267871