Otc - Active Ingredient
Clotrimazole 1%
Clotrimazole Antifungal Treatment Kit
FDA Label NDC 85398-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beautivity Llc for the product Clotrimazole Antifungal Treatment Kit (NDC 85398-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Dosage & Administration
Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tineacorporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.
Warnings
For external use only.
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Otc - When Using
avoide contact with eyes, lf contact occurs, rinse thoroughly with water.
Otc - Ask Doctor
irritation occurs or if there is no improvement within 2 weeks.
Otc - Keep Out Of Reach Of Children
lf swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
For cream
- Wash affected area & dry thoroughly.
- Apply a thin layer over affected area twice dally (morning andnight).
- Supervise children in the use of this product.
- Use daily for 2 weeks.
- Wet skin with warm water and lather soap.
- Gently massage onto affected areas.
- Rinse thoroughly and dry.
- Use twice daily or as directed by a doctor.
For soap
Inactive Ingredient
For cream:
Purifed Water, White Petrolatum, Mineral Oil, Glycerol, Cetostearyl Alcohol, Glyceryl Mono-And Distearate, Dimethyl sulfoxide, Alcohol, Polyoxyethylene Lauryl Ether (Peregal 0), Edetate Disodium, Butylated Hydroxytoluene, Ethylparaben
For soap:
Melaleuca Alternifalla (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Olil, Cocos Nucifera (Coconut) Olil,Olea Europaea (0live) Fruit Oi, Propylene Glycol, Glycerin, stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (WitchHazel)Extract, Ceramide
Storage And Handling
Store at room temperature. Protect from excessive heat (above 104°F/ 40°C)
Otc - Questions
visit us at www.hermonhealth.com
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Package (Package)
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