drug facts

drug facts
SPL v5
SPL
SPL Set ID 2f1c3e24-ea71-4634-9ec1-670349b43a50
Route
topical
Published
Effective Date 2025-10-01
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 active Since 2023-07-01

Purpose

First aid antiseptic

Description

Isopropyl alcohol (50% conc)


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
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

50% ISOPROPYL ALCOHOL

WINTERGREEN

with Methyl Salicylate

ANTISEPTIC

  • First aid antiseptic
  • For rubbing & massaging

WARNING: FLAMMABLE

Keep away from heat, spark, electrical, fire or flame

USE ONLY IN A WELL-VENTILATED AREA; FUMES MAY BE TOXIC

FL OZ (mL)

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

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

510 VOLVO PARKWAY,

CHESAPEAKE, VA 23320 USA

Package Label
Family Wellness Wintergreen Alcohol
Questions Or Comments?

1-877-753-3935

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 (1-800-222-1222).

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 gastric 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

50% ISOPROPYL ALCOHOL

WINTERGREEN

with Methyl Salicylate

ANTISEPTIC

  • First aid antiseptic
  • For rubbing & massaging

WARNING: FLAMMABLE

Keep away from heat, spark, electrical, fire or flame

USE ONLY IN A WELL-VENTILATED AREA; FUMES MAY BE TOXIC

FL OZ (mL)

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

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

510 VOLVO PARKWAY,

CHESAPEAKE, VA 23320 USA

Package Label
Family Wellness Wintergreen Alcohol
Questions Or Comments? (Questions or comments?)

1-877-753-3935

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 (1-800-222-1222).

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)