drug facts

drug facts
SPL v6
SPL
SPL Set ID c47986e9-c851-491b-817e-fd3e0b054cd4
Route
topical
Published
Effective Date 2025-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (70 mL)
Inactive Ingredients
fd&c green no. 3 fd&c yellow no. 5 methyl salicylate water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-03-19

Purpose

First aid antiseptic

Description

Isopropyl alcohol (70% 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 (70% conc.)

Principal Display Panel

Isopropyl Alcohol 70%

WINTERGREEN

First Aid Antiseptic

WARNING FLAMMABLE | keep away from heat, spark, electrical, fire or flame

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

FL OZ (mL)

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

Distributed By AmerisouceBergen

1 West First Avenue,

Conshohocken, PA 19428

Package Label
GOOD NEIGHBOR PHARMACY Isopropyl Alcohol Wintyergreen
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 (70% 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 woods, 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

Isopropyl Alcohol 70%

WINTERGREEN

First Aid Antiseptic

WARNING FLAMMABLE | keep away from heat, spark, electrical, fire or flame

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

FL OZ (mL)

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

Distributed By AmerisouceBergen

1 West First Avenue,

Conshohocken, PA 19428

Package Label
GOOD NEIGHBOR PHARMACY Isopropyl Alcohol Wintyergreen
Questions Or Comments? (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 (70% 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 woods, animal bites or serious burns.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)