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Tripleantibioticapainscaritch - Prescription Drug Labeling

Product NDC Code 69396-045
Drug Name

Tripleantibioticapainscaritch

Type Brand
Active Ingredients
Polymyxin b sulfate 10000 [usp'u]/100g
Bacitracin 500 [usp'u]/100g
Neomycin sulfate 3.5 mg/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
69396-045-01 1 tube in 1 box (69396-045-01) > 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 Adults and children 2 years 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: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient: Cocoa Butter, Levant Cottonseed Oil, Olive Oil, Petrolatum, Sodium pyruvate, vitamin E

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 Helps prevent infection in and temporarily relieves pain due to minor cuts, scrapes and burns.

Purpose

Information about the drug product’s indications for use.
Purpose First Aid Antibiotic Purpose First Aid Antibiotic Purpose First Aid Antibiotic Purpose Pain Reliever

Spl product data elements

Usually a list of ingredients in a drug product.
Tripleantibioticapainscaritch Family Wellness Bacitracin,Neomycin,PolymyxinB,PramoxineHCL SODIUM PYRUVATE PYRUVIC ACID ALPHA-TOCOPHEROL POLYMYXIN B SULFATE POLYMYXIN B OLIVE OIL PETROLATUM BACITRACIN BACITRACIN NEOMYCIN SULFATE NEOMYCIN PRAMOXINE HYDROCHLORIDE PRAMOXINE LEVANT COTTONSEED OIL COCOA BUTTER

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 pain itch scar 1oz

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 Symptoms last for more than 7 days or clear up and come back within a few days A rash or other allergic reaction develops

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product Do not use longer than 1 week

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: If you are allergic to any of the ingredients in or near the eyes on large areas of the body

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