Active Ingredient
Miconazole nitrate 2%
Miconazole Cream
FDA Label NDC 81993-010
13 label sections · Submitted to the FDA by Zennova Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zennova Llc for the product Miconazole (NDC 81993-010). 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 on children less than 2 years of age unless directed by a doctor, 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 and prevention of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea capitis).
- For relief of itching, scaling, cracking, burning and discomfort associated with these conditions.
Warnings
For external use only
Do Not Use On Children Less Than 2 Years Of Age Unless Directed By A Doctor
Do not use for diaper rash.
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 or ringworm) or 2 weeks (for jock itch).
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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 healthcare professional
- Supervise children in the use of this product.
- Wear well-fitting, ventilated shoes Change socks at least once daily.
- This product is not effective on the scalp or nails.
For athlete's foot: Use daily for 4 weeks. If condition persists, consult a healthcare professional. Pay special attention to the spaces between the toes
For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional.
For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.
Other Information
- Store at a temperature not exceeding 25°C
- Close cap tightly after use
TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
Inactive Ingredients
Benzoic Acid, Butylated Hydroxyanisole, Mineral Oil, Oleoyl Polyoxylglycerides, Polyoxyl 7 Stearate, Purified Water
Questions?
Call toll free 1-888-572-7085
Distributed By
Zennova LLC.
Princeton, NJ 08540
www.zennova.com
* Please review the disclaimer below.
