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Product NDC Code | 55621-003 | ||||
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Drug Name | Theraplus plus |
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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 | Zhejiang Jingwei Pharmaceutical Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Clotrimazole 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 -wash and dry affected area thoroughly -apply a thin layer to affected area 2 times daily -for athlete's foot and ringworm, use daily for up to 4 weeks -for jock itch, use daily for up to 2 weeks
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.glycerin, glyceryl stearate se, laureth-23, methylparaben, mineral oil, prophylparaben, stearic acid, stearyl alcohol, water Inactive Ingredients
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.relieves itching, burning, cracking, scaling and discomfort associated with: Uses -athletes foot -jock itch -ring worm
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.TheraPlus Plus CLOTRIMAZOLE GLYCERIN GLYCERYL STEARATE SE LAURETH-23 METHYLPARABEN MINERAL OIL PETROLATUM PROPYLPARABEN STEARIC ACID STEARYL ALCOHOL WATER 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.copy of label
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.. If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children
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 on the scalp or nails 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