ad8bee25-e324-9aed-e053-2995a90abd87

SPL v2
SPL
SPL Set ID ad8bee25-e324-9aed-e053-2995a90abd87
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (70 mL)
Inactive Ingredients
glycerin hydrogen peroxide water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-08-24

Purpose

ANTIMICROBIAL

Description

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic


Medication Information

Warnings

For external use only.

If taken internally, serious gastric disturbances will result.

Flammable. Keep away from fire or flame

use only in a well-ventilated area; fumes may be toxic.

Purpose

ANTIMICROBIAL

Directions
  • Clean affected area.
  • Apply small amount of this product on the area 1-3 times daily.
  • if bandaged, let dry first.
  • may be covered with a sterile bandage.
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

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 do not get into eyes.

Do not apply over large areas of the body.

Do not use longer than one week unless directed by a doctor.



Stop use and ask a doctor if condition persists or gets worse.



Keep out of reach of children. In case of infestion get medical help or contact a Poison Control Center right away (1-800-222-1222) or 911.

Do Not Use

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

236 ml NDC: 79878-003-00

3785 ml NDC: 79878-003-01

473 ml NDC: 79878-003-02

946 ml NDC: 79878-003-03


Structured Label Content

Warnings

For external use only.

If taken internally, serious gastric disturbances will result.

Flammable. Keep away from fire or flame

use only in a well-ventilated area; fumes may be toxic.

Purpose

ANTIMICROBIAL

Directions
  • Clean affected area.
  • Apply small amount of this product on the area 1-3 times daily.
  • if bandaged, let dry first.
  • may be covered with a sterile bandage.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, purified water USP

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 do not get into eyes.

Do not apply over large areas of the body.

Do not use longer than one week unless directed by a doctor.



Stop use and ask a doctor if condition persists or gets worse.



Keep out of reach of children. In case of infestion get medical help or contact a Poison Control Center right away (1-800-222-1222) or 911.

Do Not Use (Do not use)

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Package Label Principal Display Panel (Package Label - Principal Display Panel)

236 ml NDC: 79878-003-00

3785 ml NDC: 79878-003-01

473 ml NDC: 79878-003-02

946 ml NDC: 79878-003-03


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)