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

Description

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

ANTIMICROBIAL


Medication Information

Purpose

ANTIMICROBIAL

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.

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.

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.
Do Not Use

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

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

glycerin, hydrogen peroxide, purified water USP

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

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.

Purpose

ANTIMICROBIAL

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.

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.
Do Not Use (Do not use)

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

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)

glycerin, hydrogen peroxide, purified water USP

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)