3c42b124-e074-4cfc-a4ae-53bdd1b4d55d

SPL v1
SPL
SPL Set ID 3c42b124-e074-4cfc-a4ae-53bdd1b4d55d
Route
topical
Published
Effective Date 2020-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
glycerin butanediol (mixed isomers) carbomer homopolymer, unspecified type fragrance lavender & chia f-153480

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-08-12
Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v.

Medication Information

Warnings

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

Purpose

Antiseptic

Directions
  • Wet hand thoroughly and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.
Other Information
  • Store between 20°C-25°C (68-77°F).
  • May discolor certain fabrics and surfaces.
Inactive Ingredients

Glycerin, butandiol, carboxypolymethylene, fragrance, vitamin E.

Description

Ethyl Alcohol 75% v/v.

Use
  • To decrease bacteria on the skin.
  • 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.

Section 50567-7

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.

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

Ethyl Alcohol 75% v/v.

Package Label Principal Display Panel

Structured Label Content

Warnings

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

Purpose

Antiseptic

Directions
  • Wet hand thoroughly and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.
Other Information (Other information)
  • Store between 20°C-25°C (68-77°F).
  • May discolor certain fabrics and surfaces.
Inactive Ingredients (Inactive ingredients)

Glycerin, butandiol, carboxypolymethylene, fragrance, vitamin E.

Use
  • To decrease bacteria on the skin.
  • 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.

Section 50567-7 (50567-7)

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.

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

Ethyl Alcohol 75% v/v.

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:53.854922 · Updated: 2026-03-14T22:58:42.480630