Otc - Active Ingredient
Clotrimazole 1%
Roycederm Antifungal .soap. Soap
FDA Label NDC 85424-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roycederm Llc for the product Roycederm Antifungal .soap. (NDC 85424-019). 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 - when using, otc - stop use, otc - do not use, 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
Anti-fungal
Dosage & Administration
- For effective treatment of most athlete's foot(tinea pedis), ringworm(tinea corporis) and jock itch(tinea cruris).
- For effective relief of itching, burning and cracking skin.
Warnings
For external use only.
Otc - When Using
Avoid contact with the eye.
Otc - Stop Use
Stop and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot & ringworm.
Otc - Do Not Use
Do not use on children under 2 of age except under the advice and supervision of a doctor.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
- Wash affected area well and let product sit 2-3 minutes before rinsing
- Make sure to dry affected area thoroughly.
- Supervise children in the use of this product.
- For Athlete's foot: pay special attention to the spaces between the toes; wearwell-fitting, ventilated shoes and change shoes and socks at least once daily.
- Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
- This product is not effective on the scalp or nails.
Other Safety Information
Store at room temperature 59°-86°F (15°-30°C).
Inactive Ingredient
Melaleuca Alternifolia (Tea Tree) Leaf Oil, Water, Sorbitol, Elaeis Guineensis (Palm) Oil,Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin,Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Monosodium Glutamate,Sodium Hydroxide, Hamamelis Virginiana (Witch Hazel) Extract, Ceramide NP
Otc - Questions
- Visit www.roycederm.com
- Tel:+1(307)461-0958
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