Triple Antibiotic Ointment

Triple Antibiotic Ointment
SPL v3
SPL
SPL Set ID 8501adcd-97e1-bd25-e053-2a91aa0ad747
Route
TOPICAL
Published
Effective Date 2019-05-24
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 Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-03-26

Description

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

Purpose

First Aid Antibiotic Ointment


Medication Information

Warnings and Precautions

Warnings For external use only.

Indications and Usage

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

Purpose

First Aid Antibiotic Ointment

Description

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

Section 42229-5

Distributed by C.D.M.A., Inc. ©

43157 W 9 Mile Rd.

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362



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 Mineral Oil, Petrolatum

Section 51945-4

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.

Do Not Use
  • In the eyes
  • Over large areas of the body
  • If you are allergic to any of the ingredients
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 crimp for lot number and expiration date.

Other Information:

This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered trademark Neosporin®

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
Ask Doctor Before Use If You Have
  • Deep or puncture wounds
  • Animal bites
  • Serious burns
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.

Section 42229-5 (42229-5)

Distributed by C.D.M.A., Inc. ©

43157 W 9 Mile Rd.

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362



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 Mineral Oil, Petrolatum

Section 51945-4 (51945-4)

Purpose

First Aid Antibiotic Ointment

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.

Do Not Use (Do not use)
  • In the eyes
  • Over large areas of the body
  • If you are allergic to any of the ingredients
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 crimp for lot number and expiration date.

Other Information:

This product is not manufactured or distributed by

Johnson & Johnson Corporation, owner of the registered trademark Neosporin®

Stop Use and Ask A Doctor If (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
Ask Doctor Before Use If You Have (Ask Doctor before use if you have)
  • Deep or puncture wounds
  • Animal bites
  • Serious burns
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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