Otc - Active Ingredient
Tolnaftate 1.0%
Roycederm Cooldefense Refreshing Shower Gel Liquid
FDA Label NDC 85424-007
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 Cooldefense Refreshing Shower Gel (NDC 85424-007). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
anti-fungal
Indications & Usage
- Helps relieve and prevent athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
- Relieves itching, cracking, scaling, and discomfort caused by these fungal infections.
Warnings
For external use only
Otc - Do Not Use
on children under 12 years of age.
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.
Otc - Pregnancy Or Breast Feeding
If pregnancy or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of Children. In case of accidental ingestion, seek medical advice immediately or contact a poison control center right away.
Dosage & Administration
- Apply a generous amount to wet skin.
- Massage gently to create a rich lather.
- Leave on for 1-2 minutes for maximum benefits.
- Rinse thoroughly with water.
- Use daily for best results.
- For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
- This product is not effective on the scalp or nails.
Other Safety Information
Store in a cool, dry place. Keep away from direct sunlight and heat sources.
Inactive Ingredient
Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eucalyptus Globulus Leaf Oil, Menthol, Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Kernel Extract, Olea Europaea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate (Vitamin E), Citric Acid, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin
Otc - Questions
Email [email protected]
Package Label.Principal Display Panel
Shower Gel (Gel)
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