Theracare Triple Antibiotic Pain Relief Ointment

Theracare Triple Antibiotic Pain Relief Ointment
SPL v4
SPL
SPL Set ID faf73908-324f-27f5-e053-6394a90aa06e
Route
TOPICAL
Published
Effective Date 2023-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U]) Neomycin (3.5 mg) Pramoxine (10 mg) Polymyxin B (10000 [USP'U])
Inactive Ingredients
Petrolatum Light Mineral Oil Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-01

Description

Bacitracin zinc 500 Units Neomycin sulfate (3.5mg) Polymyxin B sulfate (10000 units) Pramoxine HCI (10mg)

Purpose

First Aid Antibiotic external analgesic


Medication Information

Purpose

First Aid Antibiotic

external analgesic

Description

Bacitracin zinc 500 Units Neomycin sulfate (3.5mg) Polymyxin B sulfate (10000 units) Pramoxine HCI (10mg)

Uses

First Aid to help prevent infection and for temporary relief of pain in minor:

  • Cuts
  • Scrapes
  • Burns
Warnings

For external use only.

Packaging

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 with a sterile bandage
  • Children under 2 years of age: ask doctor
Do Not Use

If you are allergic to any of the ingredients

In eyes

Over large areas of the body

Questions?

Call 866-326-1313

Active Ingredient

Bacitracin zinc 500 Units

Neomycin sulfate (3.5mg)

Polymyxin B sulfate (10000 units)

Pramoxine HCI (10mg)

Other Information

  • Store at 20° to 25°C (68° to 77°F)
  • do not use if tube seal under cap is broken
Inactive Ingredient:

Light mineral oil, hard paraffin, Petrolatum

Ask A Doctor Before Use

Ask Doctor before use if you have:

  • Deep or puncture wouns
  • Animal bites
  • Serious burns
When Using This Product

use only as directed

Keep Out of Reach of Children

If Swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

Structured Label Content

Uses

First Aid to help prevent infection and for temporary relief of pain in minor:

  • Cuts
  • Scrapes
  • Burns
Purpose

First Aid Antibiotic

external analgesic

Warnings

For external use only.

Packaging

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 with a sterile bandage
  • Children under 2 years of age: ask doctor
Do Not Use (Do not use)

If you are allergic to any of the ingredients

In eyes

Over large areas of the body

Questions?

Call 866-326-1313

Active Ingredient

Bacitracin zinc 500 Units

Neomycin sulfate (3.5mg)

Polymyxin B sulfate (10000 units)

Pramoxine HCI (10mg)

Other Information

  • Store at 20° to 25°C (68° to 77°F)
  • do not use if tube seal under cap is broken
Inactive Ingredient:

Light mineral oil, hard paraffin, Petrolatum

Ask A Doctor Before Use (Ask a Doctor before Use)

Ask Doctor before use if you have:

  • Deep or puncture wouns
  • Animal bites
  • Serious burns
When Using This Product (When using this product)

use only as directed

Keep Out of Reach of Children (Keep out of Reach of Children)

If Swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

Advanced Ingredient Data


Raw Label Data

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