Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 62e0ba7d-655c-4c73-9c2c-5b9e5c97cf54
Route
TOPICAL
Published
Effective Date 2025-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (50 mL)
Inactive Ingredients
Water Fd&c Green No. 3 Fd&c Yellow No. 5 Methyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-08-31 Until 2025-10-31

Description

Isopropyl alcohol (50% conc.)

Purpose

first aid antiseptic


Medication Information

Purpose

first aid antiseptic

Description

Isopropyl alcohol (50% conc.)

Uses

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

Warnings

For external use only.

  • if taken internally, serious gastic 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
Package Label
FAMILY WELLNESS Rubbing Alcohol 50% Isopropyl wintergreen
Other Information
  • store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
Inactive Ingredients

FD&C green #3, FD&C yellow #5, methyl salicylate, purified water

Principal Display Panel

Rubbing Alcohol 50% Isopropyl

Wintergreen with methyl salicylate

First Aid Antiseptic

WARNING: FLAMMABLE

KEEP AWAY FROM FIRE OR FLAME

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER THE CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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
Active Ingredient (by Volume)

Isopropyl alcohol (50% conc.)

Keep Out of Reach of Children.

In case of ingestion, get medical help or contact a Poison Control Center right away

Ask A Doctor Before Use If You Have
  • deep or puncture wounds, animal bites or serious burns

Structured Label Content

Uses

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

Purpose

first aid antiseptic

Warnings

For external use only.

  • if taken internally, serious gastic 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
Package Label
FAMILY WELLNESS Rubbing Alcohol 50% Isopropyl wintergreen
Other Information (Other information)
  • store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
Inactive Ingredients (Inactive ingredients)

FD&C green #3, FD&C yellow #5, methyl salicylate, purified water

Principal Display Panel

Rubbing Alcohol 50% Isopropyl

Wintergreen with methyl salicylate

First Aid Antiseptic

WARNING: FLAMMABLE

KEEP AWAY FROM FIRE OR FLAME

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER THE CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

When Using This Product (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 (Stop use and ask a doctor if)
  • condition persists or gets worse
Active Ingredient (by Volume) (Active ingredient (by volume))

Isopropyl alcohol (50% conc.)

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of ingestion, get medical help or contact a Poison Control Center right away

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds, animal bites or serious burns

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)