Theracare Triple Antibiotic Ointment Plus Pain Relief

Theracare Triple Antibiotic Ointment Plus Pain Relief
SPL v3
SPL
SPL Set ID d2374664-4668-4da5-9df7-44e6e421ad54
Route
TOPICAL
Published
Effective Date 2025-11-19
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]) Pramoxine (10 mg)
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

Bacitracin zinc Neomycin sulfate Polymyxin B Sulfate Pramoxine HCL


Medication Information

Description

Bacitracin zinc Neomycin sulfate Polymyxin B Sulfate Pramoxine HCL

Use

first aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns
Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

Section 55105-1

First aid antibiotic

External analgesic

Warnings

For external use only.

Directions
  • Adults or children 2 years of age and older:

    ■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 w th a sterile bandage 
  • Children under 2 years of age: ask a doctor
Do Not Use
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Other Information
  • store at 20° to 25°C (68° to 77° F)
  • do not use if tube seal under cap is broken
Active Ingredients
  • Bacitracin zinc
  • Neomycin sulfate
  • Polymyxin B Sulfate
  • Pramoxine HCL
Inactive Ingredients

white petrolatum

When Using This Product

use only as directed

Stop Use and Ask A Doctor If
  • you need to use longer than 1 week
  • condition persists or gets worse
  • rash or other allergic reaction develops
Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Theracare Triple Antibiotic Ointment + Pain Relief


Structured Label Content

Use

first aid to help prevent infection in minor:

  • cuts
  • scrapes
  • 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.(1-800-222-1222)

Section 55105-1 (55105-1)

First aid antibiotic

External analgesic

Warnings

For external use only.

Directions
  • Adults or children 2 years of age and older:

    ■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 w th a sterile bandage 
  • Children under 2 years of age: ask a doctor
Do Not Use (Do not use)
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Other Information (Other information)
  • store at 20° to 25°C (68° to 77° F)
  • do not use if tube seal under cap is broken
Active Ingredients
  • Bacitracin zinc
  • Neomycin sulfate
  • Polymyxin B Sulfate
  • Pramoxine HCL
Inactive Ingredients (Inactive ingredients)

white petrolatum

When Using This Product (When Using this product)

use only as directed

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you need to use longer than 1 week
  • condition persists or gets worse
  • rash or other allergic reaction develops
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns
Theracare Triple Antibiotic Ointment + Pain Relief (TheraCare Triple Antibiotic Ointment + Pain Relief)


Advanced Ingredient Data


Raw Label Data

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