Triple Antibiotic Plus Pain Relief
FDA Label NDC 67510-0670

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kareway Product, Inc. for the product Triple Antibiotic Plus Pain Relief (NDC 67510-0670). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each gram), otc - purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Gram)

Bacitracin Zinc 500 unitsNeomycin 3.5mgPolymyxin B Sulfate 10,000 unitsPramoxine HCl 10mg

Otc - Purpose

Active ingredients
(each gram contains)		Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine HCI 10 mgExternal analgesic

Uses

First aid to help prevent infection and provide temporary relief of pain or discomfort in minor
  • cuts
  • scrapes
  • burns

Warnings

For external use only

Do Not Use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask A Doctor Before Use If You Have

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop Use And Ask A Doctor If

  • you need to use longer than 1 week
  • condition persists or gets worse
  • condition persists for more than 1 week, or clear up and occur again within a few days
  • a rash or other allergic reaction develops

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and 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: consult a physician

Other Information

Store at 20°-25°C (68°-77°F)

Principal Display Panel

Triple Antibiotic Ointment + Pain Relief
Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic Ointment

Maximum Strength

Image Of Carton Label (Tripleplus.carton)

Image Of Carton Label (Tripleplus.carton)

NET WT 1 oz (28.3 g)


Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

Inactive Ingredients

white petrolatum

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