Active Ingredient
Miconazole Nitrate 2%
Antifungal Cream
FDA Label NDC 68788-8645
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals Inc. for the product Antifungal Cream (NDC 68788-8645). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet.
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 2 weeks when used for the treatment of jock itch
- there is no improvement within 4 weeks when used for athlete's foot and ringworm
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Centre right away.
Directions
- Clean the affected area and dry thoroughly.
- Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
- Supervise children in the use of this product.
- 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 4 weeks.
- For jock itch, use daily for 2 weeks.
- If condition persists longer, consult a doctor.
- This product is not effective on scalp or nails.
Other Information
- Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.
- Store at controlled room temperature.
- Preserve in tight container.
- See crimp of tube or carton for Lot Number and expiry date.
Inactive Ingredients
Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether 20, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium Phosphate Monobasic Dihydrate, White Petrolatum.
Questions?
Contact 1-800-707-4621
Manufactured in India by:
Gopaldas Visram and Company Limited.
Plot No. A327, T.T.C. Indl. Area, M.I.D.C.
Mahape, Navi Mumbai - 400710 Mfg. Lic. No.: KD/739
For BluePoint Laboratories
Relabeled By: Preferred Pharmaceuticals Inc.
NDC 68788-8645-2
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