Premier Value Triple Antibiotic Ointment

Premier Value Triple Antibiotic Ointment
SPL v3
SPL
SPL Set ID ab863d90-1a8f-3c1f-e053-2a95a90aa0a7
Route
TOPICAL
Published
Effective Date 2020-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (3.5 mg) Polymyxin B (5000 [USP'U])
Inactive Ingredients
Light Mineral Oil Squalane Petrolatum Cetyl Alcohol Stearic Acid .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-10

Description

Bacitracin zinc 400 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic


Medication Information

Warnings and Precautions

Warnings For external use only.

Do not use ● in the eyes ● over large areas of the body

● if you are allergic to any of the ingredients.

Ask a doctor before use if you have

● deep or puncture wounds ● animal bites ● serious burns.

Stop use and ask a doctor if condition persists or gets worse

● you need to use longer than 1 week

● a rash or other allergic reaction develops

Indications and Usage

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

Purpose

First aid antibiotic

Description

Bacitracin zinc 400 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 5,000 units

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredient: Cetyl Alcohol, Light Mineral Oil, Squalane, Stearic Acid, Vitamin E and Petrolatum

Section 53413-1

Questions? Call 1-866-923-4914

Packaging

Directions

Clean the affected area and dry thoroughly.

Apply a small amount of this product ( an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily.

May be covered with a sterile bandage.

Other Information

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087

Product of PRC

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Other Information

● To open: unscrew cap, pull tab to remove foil seal



● store at 20° to 25°C ( 68° to 77°F)

● see carton or tube for lot number and expiration date.

Active Ingredients (each Gram Contains)

Bacitracin zinc 400 units



Neomycin sulfate 3.5 mg



Polymyxin B sulfate 5,000 units


Structured Label Content

Indications and Usage (34067-9)

Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

Warnings and Precautions (34071-1)

Warnings For external use only.

Do not use ● in the eyes ● over large areas of the body

● if you are allergic to any of the ingredients.

Ask a doctor before use if you have

● deep or puncture wounds ● animal bites ● serious burns.

Stop use and ask a doctor if condition persists or gets worse

● you need to use longer than 1 week

● a rash or other allergic reaction develops

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredient: Cetyl Alcohol, Light Mineral Oil, Squalane, Stearic Acid, Vitamin E and Petrolatum

Section 53413-1 (53413-1)

Questions? Call 1-866-923-4914

Purpose

First aid antibiotic

Packaging

Directions

Clean the affected area and dry thoroughly.

Apply a small amount of this product ( an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily.

May be covered with a sterile bandage.

Other Information

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087

Product of PRC

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Other Information (Other information)

● To open: unscrew cap, pull tab to remove foil seal



● store at 20° to 25°C ( 68° to 77°F)

● see carton or tube for lot number and expiration date.

Active Ingredients (each Gram Contains) (Active ingredients (each gram contains))

Bacitracin zinc 400 units



Neomycin sulfate 3.5 mg



Polymyxin B sulfate 5,000 units


Advanced Ingredient Data


Raw Label Data

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