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

Purpose

first aid antiseptic

Description

Isopropyl alcohol (50% conc.)


Medication Information

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
Uses

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

Purpose

first aid antiseptic

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 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

Description

Isopropyl alcohol (50% conc.)

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

Package Label
FAMILY WELLNESS Rubbing Alcohol 50% Isopropyl wintergreen
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

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
Uses

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

Purpose

first aid antiseptic

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 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

Package Label
FAMILY WELLNESS Rubbing Alcohol 50% Isopropyl wintergreen
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)