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| Product NDC Code | 84387-002 | ||||
|---|---|---|---|---|---|
| Drug Name | Bacitracin |
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| Type | Generic | ||||
| Pharm Class | Decreased Cell Wall Synthesis & Repair [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 1648110 | ||||
| Application Number | M004 | ||||
| Labeler Name | ALLIED TRADE LINK LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGRIDIENT Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic
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.dosage and administration Clean the affected area and dry thoroughly Apply a thin layer of the cream over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for 2 weeks If condition persists longer, consult a doctor This product is not effective on the scalp or nails
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Mineral Oil, Paraffin, 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.DIRECTION 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.
Purpose
Information about the drug product’s indications for use.Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic Active Ingredient (in each gram) Purpose Bacitracin 500 units ............................................................................................................................................................................................................................................................. First Aid Antibiotic
Spl product data elements
Usually a list of ingredients in a drug product.BACITRACIN BACITRACIN WHITE PETROLATUM BACITRACIN BACITRACIN MINERAL OIL PARAFFIN
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.BACITRICIN
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.ASK A DOCTOR Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.
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 Do not use In the eyes or over large areas of the body If you are allergic to any of the ingredients Longer than 1 week unless directed by a doctor.
DO NOT USE Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops.
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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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 room temperature See crimp of tube or carton for Lot Number and Expiry Date Preserve in well-closed containers, preferably at controlled room temperature.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.USES Uses First aid to help prevent infection in minor cuts, scrapes, and burns
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
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