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| Product NDC Code | 61010-5600 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Triple antibiotic |
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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 | 204602 | ||||||||||
| Application Number | M004 | ||||||||||
| Labeler Name | Safetec of America, Inc. | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each gram) Bacitracin Zinc (400 units Bacitracin) Neomycin Sulfate (3.5 mg Neomycin) Polymyxin B Sulfate (Polymyxin B 5000 units)
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 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 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 in minor cuts, scrapes and burns
Purpose
Information about the drug product’s indications for use.Purposes First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic
Spl product data elements
Usually a list of ingredients in a drug product.Triple Antibiotic bacitracin zinc, neomycin sulfate, polymyxin b sulfate PETROLATUM BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN 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.PRINCIPAL DISPLAY PANEL – pouch Safetec Triple Antibiotic Ointment 0.9 g (1/32 oz.) Safetec of America, Inc. Buffalo, NY 14215 800-456-7077 PRINCIPAL DISPLAY PANEL – pouch
PRINCIPAL DISPLAY PANEL – 144 count box NDC 61010-5600-2 Safetec First Aid Triple Antibiotic Ointment First Aid to Help Prevent Infection in Minor Cuts, Scrapes, and Burns Reorder no. 53210 To reorder: Call: 1-800-456-7077 Fax: 716-895-2969 Online: www.safetec.com PRINCIPAL DISPLAY PANEL – 144 count box
Principal Display Panel – 10 Packet Box Label Safetec ® First Aid Triple Antibiotic Ointment Helps prevent infection in minor cuts, scrapes, and burns 10 Packets Each Packet Net. Wt. 0.9g Made in USA Reorder No. 53208 Principal Display Panel – 10 Packet Box Label
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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use: in the eyes internally over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor
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 this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store at room temperature (do not freeze) Do Not Use any Opened or Torn Packets
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? 1-800-456-7077
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: the condition persists or gets worse a rash or other allergic reaction develops
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 internally over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor Ask a doctor before use: in case of deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if: the condition persists or gets worse a rash or other allergic reaction develops Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.
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