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| Product NDC Code | 61010-5601 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Single antibiotic with bacitracin |
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| Type | Brand | ||||||
| Pharm Class | Decreased Cell Wall Synthesis & Repair [PE] | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| Application Number | M004 | ||||||
| Labeler Name | Safetec of America | ||||||
| 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 (500 units bacitracin)
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 affected area apply a small amount of this product (equal to the surface area of the tip of finger) 1 to 3 times daily may cover with a sterile bandage
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: 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, and burns.
Purpose
Information about the drug product’s indications for use.Purpose First Aid Antibiotic
Spl product data elements
Usually a list of ingredients in a drug product.Single Antibiotic with bacitracin bacitracin zinc PETROLATUM BACITRACIN ZINC BACITRACIN
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 - Box Label NDC 61010-5601-2 Safetec First Aid Single Antibiotic Ointment • with Bacitracin • First Aid to Help Prevent Infection In Minor Cuts, Scrapes, and Burns Reorder No. 53310 To reorder: Call: 1-800-456-7077 Fax: 716-895-2969 Online: www.safetec.com Principal Display Panel - Box Label
Principal Display Panel - Pouch Label Safetec Single Antibiotic Ointment (Bacitracin) 0.9 g (1/32 oz.) Safetec of America, Inc. Buffalo, NY 14215 800-456-7077 Principal Display Panel - Pouch Label
Principal Display Panel - Box Label NDC 61010-5601-3 Safetec First Aid Single Antibiotic Ointment • with Bacitracin • First Aid to Help Prevent Infection In Minor Cuts, Scrapes, and Burns 25 Packets Each Packet Net. Wt. 0.9gm Principal Display Panel - Box Label
Principal Display Panel - Pouch Label Safetec Single Antibiotic Ointment (Bacitracin) 0.9 g (1/32 oz.) Safetec of America, Inc. Buffalo, NY 14215 800-456-7077 Principal Display Panel - Pouch 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 or over large areas of the body, or on puncture wounds, animal bites or serious burns for more than 1 week unless directed by a doctor if allergic to any of the ingredients
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.For external use only. Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center directly.
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, ask a doctor if: condition persists or gets worse a rash or 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. Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center directly. Do Not Use: in the eyes or over large areas of the body, or on puncture wounds, animal bites or serious burns for more than 1 week unless directed by a doctor if allergic to any of the ingredients Stop use, ask a doctor if: condition persists or gets worse a rash or 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