61010-4400-1, Triple Antibiotic Tube

61010-4400-1, Triple Antibiotic Tube
SPL v2
SPL
SPL Set ID 03c05028-5a5f-4690-a836-cc1b1044ab39
Route
TOPICAL
Published
Effective Date 2019-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [iU]) Neomycin (5 mg) Polymyxin B (5000 [iU])
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-01

Description

Drug Facts

Purpose

First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

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, a rash or other allergic reaction develops

Section 50569-3
  • Ask a doctor before use if you havedeep or puncture wounds, animal bites, or serious burns
Warnings

For external use only

Directions

Clean the affected area. Apply a small amount (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 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
Other Information

Store at room temperature

Inactive Ingredients

White Petrolatum

Active Ingredients (in Each Gram)

Bacitracin Zinc (400 units)

Neomycin Sulfate 5mg (3.5mg Neomycin)

Polymyxin B Sulfate (5000 units)

Principal Display Panel – 1 Oz. Tube Label

Safetec®

Triple Antibiotic Ointment

First Aid Infection Protection

Net Wt. 1 oz. (28.4g)

Reorder No. 53207

Manufactured for: Safetec of America, Inc.

Buffalo, NY 14215 | 1-800-456-7077

Made in IndiaKD/503


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, a rash or other allergic reaction develops

Section 50569-3 (50569-3)
  • Ask a doctor before use if you havedeep or puncture wounds, animal bites, or serious burns
Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Warnings

For external use only

Directions

Clean the affected area. Apply a small amount (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
Other Information

Store at room temperature

Inactive Ingredients

White Petrolatum

Active Ingredients (in Each Gram) (Active Ingredients (in each gram))

Bacitracin Zinc (400 units)

Neomycin Sulfate 5mg (3.5mg Neomycin)

Polymyxin B Sulfate (5000 units)

Principal Display Panel – 1 Oz. Tube Label (Principal Display Panel – 1 oz. Tube Label)

Safetec®

Triple Antibiotic Ointment

First Aid Infection Protection

Net Wt. 1 oz. (28.4g)

Reorder No. 53207

Manufactured for: Safetec of America, Inc.

Buffalo, NY 14215 | 1-800-456-7077

Made in IndiaKD/503


Advanced Ingredient Data


Raw Label Data

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