Triple Antibiotic Ointment

Triple Antibiotic Ointment
SPL v4
SPL
SPL Set ID c47e15bd-1062-4cca-e053-2995a90a9075
Route
TOPICAL
Published
Effective Date 2021-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Neomycin (3.5 mg) Bacitracin (400 [iU]) Polymyxin B (5000 [iU])
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-15

Description

Drug Facts

Purpose

First Aid Antibiotics


Medication Information

Purpose

First Aid Antibiotics

Description

Drug Facts

Uses

First Aid to help prevent infection in minor cuts, scrapes and burns

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor ifthe condition persists or gets worse, or if a rash or other allergic reaction develops

Section 50567-7

Ask a doctor before use if you havedeep or puncture wounds, animal bites, or serious burns

Section 51945-4

Triple Antibiotic Ointment 1 oz 68001-483-45

Warnings

For external use only.

Directions

Clean the affected area. 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 or apply over large areas of the body
  • If you are allergic to any of the ingredients
  • Longer than 1 week unless directed by a doctor

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited.

Plot No. A327, T.T.C. Indl. Area, M.L.D.C.

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

For BluePoint Laboratories

Rev 09/2021

Other Information
  • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.
  • Store at room temperatue
  • Preserve in well-closed containers
  • See crimp of tube or carton for Lot Number and Expiry Date

Active Ingredients

Bacitracin Zinc (400 units in each gram)

Neomycin Sulfate 5mg (equivalent to 3.5mg Neomycin per gram)

Polymyxin B Sulfate (5000 units per gram)

Inactive Ingredients

White Petrolatum

Package Label Principal Display Panel

Triple Antibiotic Ointment 0.5 oz NDC: 68001-483-46


Structured Label Content

Uses

First Aid to help prevent infection in minor cuts, scrapes and burns

Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

Stop use and ask a doctor ifthe condition persists or gets worse, or if a rash or other allergic reaction develops

Section 50567-7 (50567-7)

Ask a doctor before use if you havedeep or puncture wounds, animal bites, or serious burns

Section 51945-4 (51945-4)

Triple Antibiotic Ointment 1 oz 68001-483-45

Purpose

First Aid Antibiotics

Warnings

For external use only.

Directions

Clean the affected area. 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)

Do not use

  • In the eyes or apply over large areas of the body
  • If you are allergic to any of the ingredients
  • Longer than 1 week unless directed by a doctor

Questions?

Contact 1-800-707-4621

Manufactured in India by:

Gopaldas Visram & Company Limited.

Plot No. A327, T.T.C. Indl. Area, M.L.D.C.

Mahape, Navi Mumbai - 400710.

Mfg. Lic. No.: KD/503

For BluePoint Laboratories

Rev 09/2021

Other Information (Other information)
  • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.
  • Store at room temperatue
  • Preserve in well-closed containers
  • See crimp of tube or carton for Lot Number and Expiry Date

Active Ingredients (Active ingredients)

Bacitracin Zinc (400 units in each gram)

Neomycin Sulfate 5mg (equivalent to 3.5mg Neomycin per gram)

Polymyxin B Sulfate (5000 units per gram)

Inactive Ingredients (Inactive ingredients)

White Petrolatum

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Triple Antibiotic Ointment 0.5 oz NDC: 68001-483-46


Advanced Ingredient Data


Raw Label Data

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