SPL v1
SPL
SPL Set ID 38bdc38a-c167-41b6-ba0d-8a114cbaf16d
Route
TOPICAL
Published
Effective Date 2020-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Glycerin Aloe Vera Leaf Phenoxyethanol Ethylhexylglycerin Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-22
Description

Ethyl Alcohol 75% v/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v.

Use

decreases bacteria on skin.

Section 50565-1

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

Section 51945-4

Warnings

For external use only.

Flammable. Keep away from heat and flame.

When using the product

  • keep out of eyes, in case of contact with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • do not inhale or ingest
  • do not reuse wipe
  • do not flush in toilet

Stop use and ask a doctor if skin irritation develops.

Directions
  • Wipe down surface thoroughly and allow to air-dry.
  • For children under 6, use only under adult supervision
  • Not recommended for infants
Product Labels

Active Ingredient

Ethyl Alcohol 75% v/v.

Other Information
  • do not store above 105°F
Inactive Ingredients

purified water, glycerin. aloe barbadensis extract, phenoxyethanol, ethylhexlyglycerin, propylene glycol

Structured Label Content

Use

decreases bacteria on skin.

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 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from heat and flame.

When using the product

  • keep out of eyes, in case of contact with eyes, flush thoroughly with water
  • avoid contact with broken skin
  • do not inhale or ingest
  • do not reuse wipe
  • do not flush in toilet

Stop use and ask a doctor if skin irritation develops.

Directions
  • Wipe down surface thoroughly and allow to air-dry.
  • For children under 6, use only under adult supervision
  • Not recommended for infants
Product Labels

Active Ingredient

Ethyl Alcohol 75% v/v.

Other Information (Other information)
  • do not store above 105°F
Inactive Ingredients (Inactive ingredients)

purified water, glycerin. aloe barbadensis extract, phenoxyethanol, ethylhexlyglycerin, propylene glycol

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:16.492337 · Updated: 2026-03-14T22:57:44.218849