FDA Label for Dermatin Antifungal
View Indications, Usage & Precautions
Dermatin Antifungal Product Label
The following document was submitted to the FDA by the labeler of this product Melaleuca, Inc.. 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
Active ingredients
Clotrimazole 1%
Otc - Purpose
Purpose
Antifungal
Indications & Usage
Uses
- Cures most athlete's foot, jock itch, and ringworm
- Relieves itching, burning, cracking, scaling, and discomfort accompanying these conditions
Warnings
Warnings
For external use only
- When using this product avoid contact with the eyes
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor
Otc - Stop Use
Stop use and ask a doctor if
- irritation occurs
- there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- clean the affected area and dry thoroughly
- apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a physician
- children under 12 years of age should be supervised in the use of this product
- for athlete's foot: pay special attention to spaces between the toes: wear well-fitting, ventilated shoes: change shoes and socks at least once daily
- for athletes foot and ringworm, use daily for 4 weeks: for jock itch, use daily for 2 weeks
- this product is not effective on scalp or nails
Inactive Ingredient
Other ingredients Water, T36 C5 Melaleuca Oil, Stearic Acid, Cetyl alcohol, SD Alcohol 40B, Glyceryl Stearate and PEG 100 Stearate, Steareth 21, Propylene Glycol, Dimethicone, Acrylates/C10-30 Alkylacrylates Crosspolymer, Triethanolamine, Steareth 2, Benzyl Alcohol, Methylsothiazolinone, BHT.
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