Otc - Active Ingredient
Miconazole Nitrate 2%
Dermachange Jock Powder
FDA Label NDC 83520-961
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Private Label Beauty And Wellness for the product Dermachange Jock (NDC 83520-961). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Indications & Usage
For the cure of athlete's foot and jock itch. Relieves itching 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 or for diaper rash. When using thisproduct avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Jock Powder
Cleanse the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily or as directed by a doctor.
Supervise children in the use of this product.
Use daily for 2 weeks.
If the condition persists, consult a doctor.
This product is not effective on the scalp or nails.
Foot Powder
Cleanse the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily or as directed by a doctor.
For athlete's foot: pay special attention to space between toes; wear well-fitting ventilated shoes and change socks at least once daily.
Supervise children in the use of this product.
Use daily for 4 weeks.
If the condition persists, consult a doctor.
This product is not effective on the scalp or nails.
Inactive Ingredient
Corn Starch, Fragrance, Potassium Sorbate, Rice Starch, Sodium Benzoate.
Package Label.Principal Display Panel
Dermachange Jock Powder, NDC 83520-961-21
Dermachange Foot Powder, NDC 83520-961-02
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