OTC Medication Information: Triple Antibiotic

TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
Discount Drug Mart, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Uses

First aid to help prevent infection 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 area of body

Ask a doctor before use if you have

  • serious burns
  • deep or puncture wounds
  • animal bites

Stop use and ask a doctor if

  • you need to use more than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week or clear up and occur again within a few days.
  • 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 or older:
    • clean the affected area
    • apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • children under 2 years of age: ask a doctor

Other information

  • store at 15° — 25° (59° to 77°F)

Inactive ingredients

Cetyl alcohol, Glycerin, Light mineral oil, Steareth-2, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum

Package label panel

Triple Antibiotic Ointment

triple.carton
(click image for full-size original)
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-987
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN 400 [USP’U] in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 5000 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
STEARETH-2
SQUALANE
STEARIC ACID
.ALPHA.-TOCOPHEROL ACETATE, D-
PETROLATUM
CETYL ALCOHOL
GLYCERIN
LIGHT MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53943-987-01 1 TUBE in 1 BOX contains a TUBE
1 14 g in 1 TUBE This package is contained within the BOX (53943-987-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 08/01/2012
Labeler — Discount Drug Mart, Inc. (047741335)

Revised: 02/2023 Discount Drug Mart, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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