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| Product NDC Code | 49406-008 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Formula 7 thegel |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 313420 | ||||||
| Application Number | M005 | ||||||
| Labeler Name | The Tetra Corporation | ||||||
| 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 Tolnaftate 1%
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: For treatment of athlete’s foot and ringworm: • Clean the affected area and dry thoroughly. Apply a thin layer of the product over the 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; 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. • If condition persists longer, consult a doctor. This product is not effective on the scalp or nails. To prevent athlete’s foot: • Wash the feet and dry thoroughly. • Apply a thin layer of the product to the feet once or twice daily (morning and/or night). • Supervise children in the use of this product. • Pay special attention to spaces between the toes; wear well-fitting,ventilated shoes, and change shoes and socks at least once daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Inactive Ingredients: Water (aqua),C12-15 Alkyl Benzoate, SimmondsiaChinensis (Jojoba) Oil, Glycerin,Oleth-10, Oleth-5, Oleth-3 Phosphate,PEG-20 Hydrogenated Lanolin,Butylene Glycol, Urea, Ethoxydiglycol,N-Acetyl-L-Cysteine, TocopherolAcetate (Vitamin E), Melaleuca Alternifolia (Tea Tree) Oil, DisodiumEDTA, Ethylhexylglycerin, CaprylylGlycol, Phenoxyethanol, Aminomethylpropanediol,Sodium Chloride.
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.For effective treatment of most athlete’s foot and ringworm. Relieves: • Itching • Scaling • Cracking • Redness • Soreness • Burning • Irritation Prevents the recurrence of most athlete’s foot (dermatophytosis) with daily use.
Purpose
Information about the drug product’s indications for use.Uses: Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Formula 7 THEGEL Tolnaftate WATER JOJOBA OIL GLYCERIN OLETH-10 OLETH-5 OLETH-3 PHOSPHATE PEG-20 HYDROGENATED LANOLIN BUTYLENE GLYCOL UREA ALKYL (C12-15) BENZOATE .ALPHA.-TOCOPHEROL ACETATE TEA TREE OIL ETHYLHEXYLGLYCERIN CAPRYLYL GLYCOL PHENOXYETHANOL ACETYLCYSTEINE AMINOMETHYLPROPANOL SODIUM CHLORIDE TOLNAFTATE TOLNAFTATE
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.Product Label Label
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.Stop use and ask a doctor if: • When using for treatment of athlete’s foot or ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. • When using for the prevention of athlete’s foot: If irritation occurs, discontinue use and consult a doctor.
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 SECTION 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 . If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-826-0479 9:00 AM to 5:30 PM EST.
Pregnancy or breast feeding
Pregnancy or Breast feedingPREGNANCY OR BREAST FEEDING If pregnant or breast-feeding ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature, 25ºC (77ºF).
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. When using this product avoid contact with eyes.
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