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| Product NDC Code | 10546-100 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Numotizine |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 1233196, 1233201 |
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| Application Number | M017 | ||||||
| Labeler Name | Hobart Laboratories, 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 Ingredients Menthol 1.25%
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 Stir in any liquid at top of jar. Keep sealed when not in use. Spread 1/8" to 1/4" of ointment to the skin. Cover the ointment with a cloth or bandage to protect clothing. Remove with warm water before totally dry (usually 8 to 12 hours). Application may be repeated every 12 hours as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Clay, Color, Fragrance of Guaiacol, Methyl Guaiacol and Oil of Wintergreen, Polyols.
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 For use as a topical analgesic Provides temporary relief of muscle pain, soreness and stiffness Temporary pain relief on strains, sprains, ligament and tendon injuries Arthritis
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.NUMOTIZINE MENTHOL KAOLIN GUAIACOL CREOSOL METHYL SALICYLATE PROPYLENE GLYCOL MENTHOL MENTHOL
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.Representative Labeling For - Numotizine Ointment 3.5oz/99g (10546-100-35) | Numotizine Ointment 8oz/228g (10546-100-08) Numotizine8 NumotizineCarton NumotizineCartonA
Package Labeling: Label Label2
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.NUMOTIZINE OINTMENT
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 the reach of children
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 Excessive irritation of the skin occurs. Persistent swellings.
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. Use only as directed. Avoid contact with eyes and mucous memebranes. Do not apply to irritated or broken skin or to large areas of the body.
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