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| Product NDC Code | 69396-045 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Tripleantibioticapainscaritch |
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| Type | Brand | ||||||||
| Pharm Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | OINTMENT | ||||||||
| RxCUI drug identifier | 1359350 | ||||||||
| Application Number | part333B | ||||||||
| Labeler Name | Trifecta Pharmaceutical USA LLC | ||||||||
| Packages |
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| Check if available Online |
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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 or Phanrmacy Near Me 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