SPL v2
SPL
SPL Set ID 28778de2-a4ce-4cda-8e9a-5edfd6cd9204
Route
TOPICAL
Published
Effective Date 2020-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Aminomethylpropanol Carbomer Homopolymer Type A Glycerin Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-19
Description

Ethyl alcohol 70% (v/v)

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 70% (v/v)

Use
  • 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. Flammable. Keep away from fire or flame.

Do not use

  • on children less than 2 months old.
  • on open skin wounds.

When using this 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.

Stop use and ask a doctor if

  • irritation or redness develops.
  • Condition persists for more than 72 hours.
Directions
  • Place 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.
Active Ingredient

Ethyl alcohol 70% (v/v)

Other Information
  • Do not store above 105°F.
  • May discolor some fabrics.
  • Harmful to wood finishes and plastics.
Inactive Ingredients

aminomethyl propanol, carbomer, homopolymer, glycerin, propylene glycol, purified water USPglycerin, hydrogen peroxide, purified water USP

Package Label Principal Display Panel

Structured Label Content

Use
  • 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. Flammable. Keep away from fire or flame.

Do not use

  • on children less than 2 months old.
  • on open skin wounds.

When using this 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.

Stop use and ask a doctor if

  • irritation or redness develops.
  • Condition persists for more than 72 hours.
Directions
  • Place 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.
Active Ingredient

Ethyl alcohol 70% (v/v)

Other Information (Other information)
  • Do not store above 105°F.
  • May discolor some fabrics.
  • Harmful to wood finishes and plastics.
Inactive Ingredients (Inactive ingredients)

aminomethyl propanol, carbomer, homopolymer, glycerin, propylene glycol, purified water USPglycerin, hydrogen peroxide, purified water USP

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: 2026-02-15T11:58:24.916174 · Updated: 2026-03-14T22:57:57.287270