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Product NDC Code | 48201-104 | ||||
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Drug Name | Pomada sulfa first aid antibiotic |
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Type | Brand | ||||
Pharm Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | OINTMENT | ||||
RxCUI drug identifier | 1544556 | ||||
Application Number | M004 | ||||
Labeler Name | GRANDALL DISTRIBUTING, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Neomycin Sulfate 0.5%
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 the product (an amount equal to surface area of the tip of a finger) on the area 1 to 3 times daily. May be covered with a single bandage.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS PETROLATUM 99.5%
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.INDICATIONS First aid to help prevent infection in minor cuts scrapes 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.POMADA SULFA FIRST AID ANTIBIOTIC NEOMYCIN SULFATE PETROLATUM NEOMYCIN SULFATE NEOMYCIN
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.01b LBL_Sulfa Edit - 01_DF 01b LBL_Sulfa Edit - 01_DF2
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.
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 or over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor. Stop use and consult a doctor if condition persists or gets worse. Do not use longer than one week unless directed by a doctor. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Store at room temperature.
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