6f23c7fa-c6ba-49e0-add0-6b858ea8bc6f

SPL v1
SPL
SPL Set ID 6f23c7fa-c6ba-49e0-add0-6b858ea8bc6f
Route
topical
Published
Effective Date 2020-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL)
Inactive Ingredients
water isopropyl alcohol glycerin aloe vera leaf denatonium benzoate

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-06-12
Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v.

Medication Information

Warnings

For external use only. 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, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Purpose

Antiseptic

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together for 15 seconds until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
  • Store between 15-300C (59-860F)
  • Avoid freezing and excessive heat above 400C (1040F)
Inactive Ingredients

Water (Aqua), Isopropyl Alcohol, Glycerin, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Denatonium Benzoate.

Description

Ethyl Alcohol 70% v/v.

Use[s]

To help reduce bacteria on the skin.

Section 50565-1

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

Active Ingredient

Ethyl Alcohol 70% v/v.

Package Label Principal Display Panel

Structured Label Content

Warnings

For external use only. 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, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Purpose

Antiseptic

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together for 15 seconds until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information (Other information)
  • Store between 15-300C (59-860F)
  • Avoid freezing and excessive heat above 400C (1040F)
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Isopropyl Alcohol, Glycerin, Fragrance (Parfum), Aloe Barbadensis Leaf Juice, Denatonium Benzoate.

Use[s]

To help reduce bacteria on the 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.

Active Ingredient

Ethyl Alcohol 70% 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: 2026-02-15T11:58:05.418624 · Updated: 2026-03-14T22:57:27.471846