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Triple antibiotic plus pain relief - Medication Information

Product NDC Code 83324-036
Drug Name

Triple antibiotic plus pain relief

Type Brand
Pharm Class Aminoglycoside Antibacterial [EPC],
Aminoglycosides [CS],
Decreased Cell Wall Synthesis & Repair [PE],
Polymyxin-class Antibacterial [EPC],
Polymyxins [CS]
Active Ingredients
Bacitracin zinc 500 [usp'u]/g
Neomycin sulfate 3.5 mg/g
Polymyxin b sulfate 10000 [usp'u]/g
Pramoxine hydrochloride 10 mg/g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 1359350
Application Number M004
Labeler Name Chain Drug Marketing Association Inc.
Packages
Package NDC Code Description
83324-036-01 1 tube in 1 box (83324-036-01) / 28.3 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (each gram contains) Bacitracin zinc 400 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 5,000 units Active Ingredient Pramoxine HCL

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 Light Mineral Oil,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 External Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Triple Antibiotic Plus Pain Relief Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate LIGHT MINERAL OIL PETROLATUM BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B PRAMOXINE HYDROCHLORIDE PRAMOXINE

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 94594 QC TRIPLE ANTIBIOTIC PAIN RELIEF OINTMENT 1OZ REV05 020224 CDER

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.
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. Other Information Distributed by CDMA., Inc. Novi, MI 48375 www.qualitychoice.com questions: 800-935-2362

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.

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 the eyes ● over large areas of the body ● if you are allergic to any of the ingredients. Ask a doctor before use if you have ● deep or puncture wounds ● animal bites ● serious burns. 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

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