SPL v1
SPL
SPL Set ID ae1c7a60-d13b-1b86-e053-2995a90a1689
Route
TOPICAL
Published
Effective Date 2022-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (30 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Rubbing Alcohol


Medication Information

Purpose

Antiseptic, Rubbing Alcohol

Description

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Use

First aid to help prevent the risk of infection in minor cuts, scrapes, and burns.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Section 51945-4

Warnings

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

Directions
  • Clean the affacted area
  • Apply a small amount of this product 1 to 3 times daily.
  • May be covered with a sterile bandage. If bandaged, let dry first.
  • 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
  • with electrocautery procedures
  • on open skin wounds
  • longer than 1 week unless directed by a doctor
  • over large areas of the body
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

purified water


Structured Label Content

Use

First aid to help prevent the risk of infection in minor cuts, scrapes, and burns.

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 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 51945-4 (51945-4)

Purpose

Antiseptic, Rubbing Alcohol

Warnings

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

Directions
  • Clean the affacted area
  • Apply a small amount of this product 1 to 3 times daily.
  • May be covered with a sterile bandage. If bandaged, let dry first.
  • 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
  • with electrocautery procedures
  • on open skin wounds
  • longer than 1 week unless directed by a doctor
  • over large areas of the body
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

purified water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)