SPL v4
SPL
SPL Set ID eaf57fdb-d4e0-4893-90e3-0c532c921698
Route
TOPICAL
Published
Effective Date 2020-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Butylene Glycol Glycerin Lanolin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-20
Description

Alcohol 70% v/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v.

Use

Antiseptic wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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

Section 50567-7

When using this productkeep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

Warnings

For external use only. Flammable. Keep away from heat or flame. Keep out of reach of children.

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Alcohol 70% v/v.

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

Glycerin, Butylene Glycol, Water, Lanolin

Package Label Principal Display Panel

Structured Label Content

Use

Antiseptic wipe to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this productkeep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame. Keep out of reach of children.

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Alcohol 70% v/v.

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

Glycerin, Butylene Glycol, Water, Lanolin

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: 2026-02-15T12:02:21.509805 · Updated: 2026-03-14T23:01:51.692931