FDA Label for Soothe And Cool Treat
View Indications, Usage & Precautions
Soothe And Cool Treat Product Label
The following document was submitted to the FDA by the labeler of this product Medline Industries, Lp. 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.
Active Ingredient
Miconazole Nitrate 2%
Purpose
Antifungal
Uses
- For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
- For the treatment of superficial skin infections caused by yeast (candida albicans)
- Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
Warnings
For external use only
Do Not Use
- on children under 2 years of age unless directed by a doctor
When Using This Product
- avoid contact with the eyes
Stop Use And Ask A Doctor
■ if irritation occurs ■ there is no improvement within 4 weeks for athlete’s foot and ringworm ■ there is no improvement within 2 weeks for jock itch
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ Clean the affected area and dry thoroughly ■ Apply a thin layer over affected area twice daily or as directed by a physician ■ Supervise use by children ■ For athlete’s foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily ■ For athlete’s foot and ringworm, use daily for four weeks ■ For jock itch, use daily for two weeks ■ If condition persists longer, consult a doctor ■ This product is not effective on scalp or nails
Other Information
- Protect from freezing. Avoid excessive heat.
Inactive Ingredients
Allantoin, Bees Wax, Cetyl Dimethicone, Cetyl PEG/PGG-10/1 Dimethicone, Fragrance, Hydrogenated Castor Oil, Imidazolidinyl Urea, Isopropyl Palmitate, Petrolatum, Polymethoxy Bicyclic Oxazolidine, Sodium Chloride, Water, Zinc Oxide.
Other
www.medline.com
Manufactured in USA for Medline Industries, Inc.,
Mundelein, IL 60060 USA. 1-800-MEDLINE RF15SAP
Principal Display Panel - 5 Fl Oz
NDC 53329-080-57
Soothe&Cool
TREAT
INZO Antifungal Cream
- Miconazole Nitrate 2%
- Treats fungal infections
- Aids in maintaining healthy skin
5 oz (141.7 mL)
REF MSC095635
* Please review the disclaimer below.