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| Product NDC Code | 82460-344 | ||||
|---|---|---|---|---|---|
| Drug Name | Simply vital antifungal cream |
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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 | CREAM | ||||
| RxCUI drug identifier | 309367 | ||||
| Application Number | M005 | ||||
| Labeler Name | ALPHA PLANTS 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 Clotrimazole 1.00% Purpose Antifungal
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 and dry thoroughly. apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. supervise children in the use of this product. for athlete's foot: Pay special attention to spaces between the toes; weat 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. if condition persists longer, consult a doctor. this product is not effective on the scalp or nails.
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), Cetearyl Alcohol, Cetyl Stearate, Ethylhexyl Palmitate, Ethylhexylglycerin, Glycerin, Hamamelis Virginiana (Witch Hazel), Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Sorbitan Stearate, Thymus Vulgaris (Thyme) Extract, Tocopheryl Acetate (Vitamin 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.Uses: proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm. for effective relief of itching, scaling, burning, soreness, irritation and discomfort.
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.SIMPLY VITAL Antifungal Cream CLOTRIMAZOLE ALOE VERA LEAF WATER CETOSTEARYL ALCOHOL CETYL STEARATE ETHYLHEXYL PALMITATE ETHYLHEXYLGLYCERIN GLYCERIN HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK TEA TREE OIL PHENOXYETHANOL POLYSORBATE 20 PROPYLENE GLYCOL SORBITAN MONOSTEARATE THYME .ALPHA.-TOCOPHEROL ACETATE TROLAMINE 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: 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.Drug Facts
Other information: protect the product in this container from excessive heat and direct sun.
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 on children under 2 years of age unless directed by a 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. get medical help or contact a Poison Control Center right away. If swallowed,
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? +1 (205) 624-9177
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 the eyes irritation occurs. condition persists. there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks. Discontinue use and ask a doctor if
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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 on children under 2 years of age unless directed by a doctor When using this product avoid contact with the eyes irritation occurs. condition persists. there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks. Discontinue use and ask a doctor if Keep out of reach of children. get medical help or contact a Poison Control Center right away. If swallowed, If pregnant or breast-feeding, ask a health professional before use.
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