Otc - Active Ingredient
Clotrimazole 1%
Roycederm Antifungal .spray. Spray
FDA Label NDC 85424-026
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 .spray. (NDC 85424-026). 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 - keep out of reach of children, indications & usage, other safety information, inactive ingredient, 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
- For effective treatment of most athlete's foot(tineapedis), ringworm(tinea corporis) and jock itch(tinea cruris).
- For effective relief of itching, burning and cracking skin.
Warnings
For external use only.
When using this product
Avoid contact with the eye
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 and ringworm.
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
- 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 ofthis product.
- for athlete's foot: pay special attention to the spaces between the toes; wear well-fitting,ventilated shoes and change shoes & 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.
Other Safety Information
Store at room temperature 59°-86°F (15°-30°C).
Inactive Ingredient
Alcohol, Water, Propylene Glycol,PEG-40 Hydrogenated CastorOil, Melaleuca Alternifolia LeafOil, Oleth-20, PEG-60 Hydrogenated Castor Oil, Laurocapram,Mentholum, Mentha Piperita Oil,PEG-8, Nonoxynol-20, Allantoin,Aloe Barbadensis Leaf Juice,Panthenol.
Otc - Questions
Visit www.roycederm.com
Tel:+1(307)461-0958
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