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| Product NDC Code | 71262-007 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Vitastem ultra |
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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 | ViaDerma Distribution, Inc | ||||||
| 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 Ingredient Bacitracin Zinc (500 units Bacitracin in 1g) Purpose 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.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 this product is an OTC antibiotic for human use contains no alcohol, no animal ingredients blended for typical skin color no claims regarding stem cell healing are implied for this product Stop use if product is misused
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxethyl cellulose, magnesium stearate, sodium hydroxide, sorbic acid, stearic acid, water
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 the risk of skin infection in minor cuts, scrapes, or 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.Vitastem ULTRA BACITRACIN ZINC ACETIC ACID ASCORBIC ACID CHLORHEXIDINE GLUCONATE CHOLECALCIFEROL DIMETHYL SULFOXIDE DIPROPYLENE GLYCOL GLUCONOLACTONE GLYCERIN HISTIDINE HYDROXYETHYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE SODIUM HYDROXIDE SORBIC ACID STEARIC ACID WATER 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.Package Labeling:71262-007-15 Outer Package2 Inner Package2
Package Labeling:71262-007-55 Outer Package3 Inner Package3
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
Other Information store in a cool dry place
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 before use if you have deep or punture wounds animal bites serious trauma
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 eyes over large areas of the body longer than 1 week unless directed by 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 out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 condition persists or gets worse.
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. May be harmful if swallowed. Allergy Alert Do not use if allergic to any ingredients in VitaStem™ ULTRA. Do not use in eyes over large areas of the body longer than 1 week unless directed by doctor Ask a doctor before use if you have deep or punture wounds animal bites serious trauma Stop use and ask a doctor if condition persists or gets worse. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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