Otc - Active Ingredient
Clotrimazole 1%
Roycederm Tea Tree Oil Antifungal .spray. Spray
FDA Label NDC 85424-024
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 Tea Tree Oil Antifungal .spray. (NDC 85424-024). 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, other safety information, indications & usage, 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(tinea pedis), ringworm(tinea corporis) & 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 ifthere is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot & righworm.
Do not use on children under 2 of age except under the advice ad supervision of a doctor.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Other Safety Information
Store at room temperature 59°-86°F(15°-30°C).
Indications & Usage
- Clean the affected area and dry thoroughly.
- Spray a thin layer of the product over affected area twice daily(morning and night), or as directed by a doctor.
- Supervise children in the useof this product.
- For Athlete's foot: payspecial attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks atleast 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 adoctor.
- This product is not effective on the scalp or nails.
Inactive Ingredient
Water, Alcohol Denat. Propylene Glycol,PEG-40 Hydrogenated Castor Oil,Melaleuca Alternifolia (Tea Tree) Leaf Oil,PEG-60 Hydrogenated Castor Oil,Oleth-20, Laurocapram, Mentha Piperita(Peppermint) Oil, Nonoxynol-20, PEG-8,Aloe Barbadensis Leaf Juice,Panthenol, Allantoin.
Otc - Questions
Visit www.roycederm.com
Tel: +1(307)461-0958
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