Active Ingredient
Miconazole Nitrate 2%
Happy Nuts Jock Itch Powder
FDA Label NDC 87151-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Suit Up Brands Llc for the product Happy Nuts Jock Itch Powder (NDC 87151-111). 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, indications & usage, 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
Indications & Usage
for the cure of most jock itch (tinea cruris). Relieves itching, burning, cracking, scaling and discomfort 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 dyes.
Stop Use And Ask A Doctor If
- irritation occurs
- there is no improvement within 2 weeks
Keep Out Of Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Clean affected area thoroughly.
- Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
- Supervise children when using this product
- Use daily for 2 weeks
- If condition persists longer, consult a doctor
- This product is not effective on the scalp or nails
Inactive Ingredients
Corn Starch, Fragrance, Potassium Sorbate, Rice Starch, Sodium Benzoate
Recent Major Changes
The title for this section was corrected.
Package Label.Principal Display Panel
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