A

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SPL v3
SPL
SPL Set ID 42521691-2b8f-48fc-80a4-baad0374566d
Route
TOPICAL
Published
Effective Date 2015-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (50 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-12-18

Description

Isopropyl alcohol (50% conc.)

Purpose

first aid antiseptic


Medication Information

Warnings and Precautions

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

Indications and Usage

Uses

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

Purpose

first aid antiseptic

Dosage and Administration

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

Description

Isopropyl alcohol (50% conc.)

Section 42229-5

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

Section 44425-7

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

Section 50565-1

Keep this drug out of the reach of children

• Incase of an accidental ingestion, seek professional assistance or contact a doctor immediately

Section 51727-6

Inactive Ingredient Water(Aqua)

Packaging

Drug Facts

Active Ingredients (by Volume):

Isopropyl alcohol (50% conc.)


Structured Label Content

Indications and Usage (34067-9)

Uses

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

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

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

Keep this drug out of the reach of children

• Incase of an accidental ingestion, seek professional assistance or contact a doctor immediately

Section 51727-6 (51727-6)

Inactive Ingredient Water(Aqua)

Purpose

first aid antiseptic

Packaging

Drug Facts

Active Ingredients (by Volume): (Active ingredients (by volume):)

Isopropyl alcohol (50% conc.)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)