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Product NDC Code | 37835-904 | ||||||||
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Drug Name | Triple antibiotic plus pain relief |
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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 | ||||||||
Application Number | M004 | ||||||||
Labeler Name | Bi-Mart | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (in each gram) Bacitracin Zinc 400 units Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin) Polymyxin B Sulfate 10000 units Pramoxine Hydrochloride 10 mg
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 of age and older clean 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 of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient White 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 and for the temporary relief of pain in minor: cuts scrapes burns
Purpose
Information about the drug product’s indications for use.Purposes First aid antibiotic First aid antibiotic First aid antibiotic 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, Pramoxine Hydrochloride WHITE 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.Principal Display Panel NDC 37835-904-01 Triple Antibiotic Ointment + Pain Relief First Aid Antibiotic/Pain Relieving Ointment Compare to the Active Ingredients in Neosporin ® + Pain Relief * *This product is not manufactured or distributed by Johnson & Johnson Corporation Products Company, Inc, owner of the registered trademark Neosporin ® + Pain Relief . Net. Wt. 1 oz (28.4 g) Distributed by: Bi-Mart Eugene, OR 97402 Carton
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 (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information do not use if seal on the tube is damaged or is not visible. to open, unscrew cap, pull tab to remove foil seal. Store at 20° to 25°C (68° to 77°F) avoid excessive heat and humidity see crimp of tube or carton for Lot Number and Expiry Date
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-800-935-6737
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 the eyes over large areas of the body Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse symptoms persist for more than 1 week, or clear up and occur again within a few day 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