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Product NDC Code | 55681-218 | ||||||
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Drug Name | Procurefirst aid antibio first aid antibiotic |
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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 | ||||||
RxCUI drug identifier | 1366116 | ||||||
Application Number | M004 | ||||||
Labeler Name | TWIN MED, LLC | ||||||
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 (equal to 500 Bacitracin 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 small amount of this product(an amount equal to the surface area of the tip of the 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 Ingredients Hard Paraffin, Lanolin, Liquid Paraffin,White Soft Paraffin
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 prevent infection in Minor cuts, Scrapes & Burns
Purpose
Information about the drug product’s indications for use.Purpose Antibiotic
Spl product data elements
Usually a list of ingredients in a drug product.procureFirst Aid Antibio First Aid Antibiotic BACITRACIN PARAFFIN LANOLIN MINERAL OIL 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 Drug Fact and PDP
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 If you are allergic to any of the ingredients, due to possibility of anaphylactic shock Over large areas of the body 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
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 Centre 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 Store at controlled room temperature 15 o - 30 o C(59 o- -86 o F) Avoid excessive heat and humidity Tamper Evident Do not use if packet is torn, cut, or opened.
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 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 If you are allergic to any of the ingredients, due to possibility of anaphylactic shock Over large areas of the body 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 allergic reaction develops Keep out of reach of children If swallowed, get medical help or contact a Poison Control Centre right away Other information Store at controlled room temperature 15 o - 30 o C(59 o- -86 o F) Avoid excessive heat and humidity Tamper Evident Do not use if packet is torn, cut, or opened. Inactive Ingredients Hard Paraffin, Lanolin, Liquid Paraffin,White Soft Paraffin
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