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| Product NDC Code | 70673-747 | ||||
|---|---|---|---|---|---|
| Drug Name | Smooth gator fungus eliminator |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 309370 | ||||
| Application Number | M005 | ||||
| Labeler Name | Smooth Gator, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients: Clotrimazole 1.00% Purpose: Antifungal Treatment
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: Read all package directions and warnings before using. • Use only as directed. • Clean the affected area with soap and warm water and dry thoroughly. • Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor. • Avoid applying to severely cracked or irritated areas. • For athlete’s foot: pay special attention to spaces between 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. • Supervise children in the use of this product. • Intended for use by normally healthy adults only. • Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: BHT, Carthamus Tinctorius (Safflower) Oil, Emu Oil, Eucalyptus Globulus(Eucalyptus) Oil, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavender) Oil, Malaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Olea Europaea (Olive) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Tocopheryl Acetate (Vitamin E).
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 the cure of most • athlete’s foot (tinea pedis) • ringworm (tinea corporis) • jock itch (tinea cruris) For relief of • itching • scaling • cracking • burning • redness • soreness • irritation • discomforts which may accompany these conditions.
Purpose
Information about the drug product’s indications for use.Purpose: Antifungal Treatment
Spl product data elements
Usually a list of ingredients in a drug product.Smooth Gator Fungus Eliminator CLOTRIMAZOLE BUTYLATED HYDROXYTOLUENE SAFFLOWER EMU OIL EUCALYPTUS OIL SOYBEAN OIL HELIANTHUS ANNUUS FLOWERING TOP LAVENDER OIL TEA TREE OIL PEPPERMINT OIL OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES ALMOND OIL .ALPHA.-TOCOPHEROL ACETATE CLOTRIMAZOLE CLOTRIMAZOLE
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: label
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: Apply to skin around affected areas. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use until satisfactory results are obtained.
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 on children under 2 years of age.
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 RICH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately
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 doctor if Irritation occurs or there is no improvement within 4 weeks (2 weeks for jock itch).
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.When using this product avoid contact with eyes.
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. Ask a doctor before use on children under 2 years of age. When using this product avoid contact with eyes. Stop use and ask doctor if Irritation occurs or there is no improvement within 4 weeks (2 weeks for jock itch). KEEP OUT OF RICH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately
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