drug facts

drug facts
SPL v10
SPL
SPL Set ID f9ff67b0-c4ad-4162-b3ef-27a85ed0da25
Route
topical
Published
Effective Date 2025-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (50 mL)
Inactive Ingredients
fd&c green no. 3 fd&c yellow no. 5 methyl salicylate water

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug active Since 2014-06-30

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% Rubbing Alcohol

Isopropyl

wintergreen

first aid antiseptic

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

FLAMMABLE

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

Manufactured by:

PL Developments

513 Old Griffin Road

Piedmont, SC 29673

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

WARNING: FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME

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

FL OZ(mL)

Package Label
READYinCASE First Aid Antiseptic
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% Rubbing Alcohol

Isopropyl

wintergreen

first aid antiseptic

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

FLAMMABLE

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

Manufactured by:

PL Developments

513 Old Griffin Road

Piedmont, SC 29673

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

WARNING: FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME

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

FL OZ(mL)

Package Label
READYinCASE First Aid Antiseptic
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)