SPL v1
SPL
SPL Set ID 423c20db-abb9-4a21-b3c0-ee3d82706e5f
Route
TOPICAL
Published
Effective Date 2020-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Butanediol (mixed Isomers) Carboxypolymethylene .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-26
Description

Ethyl Alcohol 75% v/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v.

Use[s]
  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use
Section 50565-1

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

Warnings

For external use only- hands.

Flammable, keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product

  • keep out of eyes, in case of contact with eyes, rinse eyes thoroughly with water.
  • avoid contact with broken skin.
  • do not inhale or ingest.

Stop use and ask a doctor if skin irritation develops.

Directions
  • Wet hand thoroughly and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.
Active Ingredient

Ethyl Alcohol 75% v/v.

Other Information
  • Store between 20°C-25°C (68-77°F).
  • May discolor certain fabrics and surfaces.
Inactive Ingredients

Glycerin, Bitandiol, Carboxypolymethylene, Vitamin E.

Package Label Principal Display Panel

Structured Label Content

Use[s]
  • to decrease bacteria on the skin that could cause disease
  • recommended for repeated use
Section 50565-1 (50565-1)

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

Purpose

Antiseptic

Warnings

For external use only- hands.

Flammable, keep away from heat or flame.

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product

  • keep out of eyes, in case of contact with eyes, rinse eyes thoroughly with water.
  • avoid contact with broken skin.
  • do not inhale or ingest.

Stop use and ask a doctor if skin irritation develops.

Directions
  • Wet hand thoroughly and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.
Active Ingredient

Ethyl Alcohol 75% v/v.

Other Information (Other information)
  • Store between 20°C-25°C (68-77°F).
  • May discolor certain fabrics and surfaces.
Inactive Ingredients (Inactive ingredients)

Glycerin, Bitandiol, Carboxypolymethylene, Vitamin E.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:57:53.928474 · Updated: 2026-03-14T22:57:12.244689