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| Product NDC Code | 70673-501 | ||||
|---|---|---|---|---|---|
| Drug Name | Smooth gator head-ezz analgesic |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1442261 | ||||
| Application Number | M017 | ||||
| Labeler Name | Smooth Gator 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 Ingredients: Menthol 3.00% Purpose Topical Analgesic
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: Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camphor, Diazolidinyl Urea, Eucalyptus Globulus Oil, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methyl Paraben, Methyl Salicylate, Mineral Oil, Parfum (Fragrance), PEG-100 Stearate, Polysorbate-20, Propyl Paraben, Propylene Glycol, Retinyl Palmitate (Vitamin E), Rosmarinus Officinalis (Rosemary) Extract, Tocopheryl Acetate (Vitamine E), Triethanolamine.
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: For the temporary relief of minor aches and pains.
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.SMOOTH GATOR Head-Ezz Analgesic MENTHOL ALOE VERA LEAF WATER DIAZOLIDINYL UREA EUCALYPTUS OIL GLYCERIN GLYCERYL MONOSTEARATE LICORICE MELALEUCA ALTERNIFOLIA LEAF PEPPERMINT OIL METHYLPARABEN METHYL SALICYLATE MINERAL OIL PEG-100 STEARATE POLYSORBATE 20 PROPYLPARABEN PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ROSEMARY TROLAMINE 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.Package Labelling: Bottle
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
Additional Information: Store at room temperature
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, consult physician. Do not apply to wounds or damaged skin. Do not bandage tightly.
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. Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician. Keep out of reach of children. If swallowed, consult physician. Do not apply to wounds or damaged skin. Do not bandage tightly.
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