Active Ingredients
Miconazole nitrate 2%
Sulfur 5%
Camphor 1%
Menthol 1%
Rommy Jean-pierre Llc Anti-fungal Cream
FDA Label NDC 87306-126
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rommy Jean-pierre Llc for the product Rommy Jean-pierre Llc Anti-fungal Cream (NDC 87306-126). 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 ingredients, purpose, indications & usage, warnings, otc - keep out of reach of children, otc - when using, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Keratolytic
External Analgesic
Indications & Usage
Cures most athlete’s foot, jock itch, and ringworm
Relieves itching, burning, cracking, and scaling associated with these conditions
Helps relieve itching and discomfort associated with minor skin irritation
Helps loosen and remove excessive dead skin and flakes
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 eyes
do not apply to broken or severely irritated skin
Stop use and ask a doctor if:
irritation occurs
condition worsens
symptoms persist for more than 4 weeks
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - When Using
Avoid contact with eyes
Do not apply to broken or severely irritated skin
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor
Otc - Stop Use
Stop use and ask a doctor if irritation occurs or if condition worsens
Dosage & Administration
Clean and dry the affected area before applying
Apply a thin layer to the affected area twice daily (morning and night)
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
Storage And Handling
Store at 20°–25°C (68°–77°F)
Excursions permitted between 15°–30°C (59°–86°F)
Protect from excessive heat and direct sunlight
Do Not Freeze
Inactive Ingredient
Aloe barbadensis leaf juice, carthamus tinctorius (safflower) seed oil, petrolatum, peppermint oil, thymol, alpha-tocopherol acetate
Otc - Questions
Questions or comments?
Email [email protected]
* Please review the disclaimer below.
