OTC Medication Information: A 50% ISOPROPYL Rubbing Alcohol

A 50% ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid
JT Cosmetics and Chemicals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (by volume):

Isopropyl alcohol (50% conc.)

Purpose

first aid antiseptic

Keep this drug out of the reach of children
• Incase of an accidental ingestion, seek professional assistance or contact a doctor immediately

Uses
• First aid to help prevent the risk of infection in minor cuts, scrapes and burns

Warnings
• For external use only; flammable, keep away from fire or flame, heat, spark, electrical, etc.

Ask a doctor before use if you have
• Deep punctured wounds, animal bites or serious burns

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 using this product if
• Condition persists or gets worse

Directions
• Clean affected area
• Apply small amount of this product on the area 1-3 times daily
• You can cover it with a sterile bandage
• If bandaged, let dry first

Inactive Ingredient Water(Aqua)

Other information
• Store at room temperature
• Does not contain, nor is intended as a substitute for grain or ethyl alcohol. Will produce serious gastric disturbances if taken internally

FIRST AID ANTISEPTIC

For Rubbing & Massaging

Use only in a well ventilated area

Fumes may be harmful

WARNING FLAMMABLE
Keep away from fire or flame!

TAMPER EVIDENT: DO NOT USE IF THE UNDER CAP SAFETY FOIL IS BROKEN OR MISSING

Distributed By:
JMD ALL STAR IMPEX INC., Edison, NJ — 08817

DESIGNED IN THE USA

Packaging

ispa
(click image for full-size original)

A 50% ISOPROPYL RUBBING ALCOHOL isopropyl alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69859-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 50 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69859-003-55 355 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 12/18/2015
Labeler — JT Cosmetics and Chemicals (650884849)
Establishment
Name Address ID/FEI Operations
JT Cosmetics and Chemicals 650884849 manufacture (69859-003)

Revised: 12/2015 JT Cosmetics and Chemicals

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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