FDA Label for Roycederm Cooldefense Refreshing Shower Gel
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Roycederm Cooldefense Refreshing Shower Gel Product Label
The following document was submitted to the FDA by the labeler of this product Roycederm Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Tolnaftate 1.0%
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
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