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Tripleantibioticointmentandpainrelief - Prescription Drug Labeling

Product NDC Code 69396-044
Drug Name

Tripleantibioticointmentandpainrelief

Type Brand
Pharm Class Aminoglycoside Antibacterial [EPC],
Aminoglycosides [CS],
Decreased Cell Wall Synthesis & Repair [PE],
Polymyxin-class Antibacterial [EPC],
Polymyxins [CS]
Active Ingredients
Bacitracin 500 [usp'u]/100g
Neomycin sulfate 3.5 mg/100g
Polymyxin b sulfate 10000 [usp'u]/100g
Pramoxine hydrochloride 10 mg/100g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 1359350
Application Number part333B
Labeler Name Trifecta Pharmaceutical USA LLC
Packages
Package NDC Code Description
69396-044-01 1 tube in 1 box (69396-044-01) > 28.4 g in 1 tube

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Bacitracin 500 Units Active Ingredient Neomycin 3.5mg Active Ingredient Polymyxin B 10,000 Units Active Ingredient Pramoxine HCL 10mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Clean the affected area and dry thoroughly 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient: Petrolatum

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses First Aid to help prevent infection in minor: Cuts Scrapes Burns

Purpose

Information about the drug product’s indications for use.
Purpose First Aid Antibiotic Purpose First Aid Antibiotic Purpose First Aid Antibiotic Purpose External Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Tripleantibioticointmentandpainrelief Family Wellness Bacitracin,Neomycin,PolymyxinB,Pramoxine PETROLATUM BACITRACIN BACITRACIN NEOMYCIN SULFATE NEOMYCIN PRAMOXINE HYDROCHLORIDE PRAMOXINE POLYMYXIN B SULFATE POLYMYXIN B

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Packaging family wellness triple antibiotic plus pain ointment

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
DRUG FACTS

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a Doctor before Use Ask Doctor before use if you have: Deep or puncture wouns Animal bites Serious burns

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of Reach of Children If Swallowed, get medical help or contact a Poison Control Center right away

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Call 1-888-296-9067 Weekdays 9AM - 4PM EST DISTRIBUTED BY: MIDWOOD BRANDS, LLC. 500 Volvo Parkway, Chesapeake, VA. 23320 NOT SATISFIED? Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange. This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin® Plus Pain Relief.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop Use and ask a Doctor if: Condition persists or gets worse You need to use longer than 1 week A rash or other allergic reaction develops

Storage and handling

Information about safe storage and handling of the drug product.
Other Information To Open: Unscrew cap, pull tab to remove foil seal Store at 20° to 25°C (68° to 77°F) See carton or tube crimp for lot number and expiration date

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only. Do not use: In eyes Over large areas of the body If you are allergic to any of the ingredients

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API