Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID edb84ac1-f002-473a-82b0-71d5cf1424ed
Route
TOPICAL
Published
Effective Date 2022-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-03-18

Description

Bacitracin Zinc (400 units Bacitracin) Neomycin sulfate (3.5 mg Neomycin) Polymyxin B Sulfate (Polymyxin B 5000 units)

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic


Medication Information

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Description

Bacitracin Zinc (400 units Bacitracin) Neomycin sulfate (3.5 mg Neomycin) Polymyxin B Sulfate (Polymyxin B 5000 units)

Uses

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

Section 50565-1

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

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:
  • in the eyes
  • internally
  • 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 (do not freeze)
  • do Not Use any Opened or Torn Packets
Inactive Ingredient

petrolatum

Questions Or Comments?

1 -800-456-7077

Ask A Doctor Before Use:
  • in case of deep or puncture wounds, animal bites, or serious burns
Stop Use and Ask A Doctor If:
  • the condition persists or gets worse
  • a rash or other allergic reaction develops
Active Ingredients (in Each Gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 5000 units)

Principal Display Panel 0.5 G Box Label

NDC 70082-603-04

dealmed

Triple

Antibiotic

Ointment

First Aid to help prevent

infection in minor cuts,

scrapes and burns

144

PACKETS

NET WT. 0.5g

PER PACKET

Principal Display Panel 0.5g Pouch Label

dealmed

Triple Antibiotic

Ointment

0.5g (1/57 oz.)

Dealmed • Brooklyn, NY

www.dealmed.com


Structured Label Content

Uses

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

Section 50565-1 (50565-1)

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

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

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
  • internally
  • 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 (do not freeze)
  • do Not Use any Opened or Torn Packets
Inactive Ingredient (Inactive ingredient)

petrolatum

Questions Or Comments? (Questions or Comments?)

1 -800-456-7077

Ask A Doctor Before Use: (Ask a doctor before use:)
  • in case of deep or puncture wounds, animal bites, or serious burns
Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • the condition persists or gets worse
  • a rash or other allergic reaction develops
Active Ingredients (in Each Gram) (Active Ingredients (in each gram))

Bacitracin Zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 5000 units)

Principal Display Panel 0.5 G Box Label (Principal Display Panel - 0.5 g Box Label)

NDC 70082-603-04

dealmed

Triple

Antibiotic

Ointment

First Aid to help prevent

infection in minor cuts,

scrapes and burns

144

PACKETS

NET WT. 0.5g

PER PACKET

Principal Display Panel 0.5g Pouch Label (Principal Display Panel - 0.5g Pouch Label)

dealmed

Triple Antibiotic

Ointment

0.5g (1/57 oz.)

Dealmed • Brooklyn, NY

www.dealmed.com


Advanced Ingredient Data


Raw Label Data

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