Private Label Antifungal Barrier Cream
FDA Label NDC 60232-0046

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Swiss-american Cdmo, Llc for the product Private Label Antifungal Barrier Cream (NDC 60232-0046). 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 warnings, active ingredients, indications & uses, directions, keep out of reach of children, inactive ingredients, questions?, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings

For external use only. Not intended for ingestion. Do not use on children under 2 year of age unless directed by a doctor. Avoid contact with the eyes. For the treatment of athlete’s foot and ringworm. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. For the prevention of athlete’s foot: if irritation occurs, discontinue use and consult a doctor. Do not use for diaper rash. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients

Miconazole Nitrate 2.0%

Indications & Uses

Proven clinically effective in the treatment of most athlete’s foot (tinea pedia), jock itch (tinea cruris) and ringworm (tinea corporis). For the treatment of superficial skin infections caused by yeast (candida albicans). For effective relief of redness, irritation, scaling, itching, discomfort and burning.

Directions

Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily as directed by a doctor or health care professional. 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 the scalp or nails.

Keep Out Of Reach Of Children

Keep out of reach of children

Inactive Ingredients

Allantoin, bees wax, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, ethylhexylglycerin, fragrance, hydrogenated castor oil, isopropyl palmitate, petrolatum, phenoxyethanol, purified water, sodium chloride, zinc oxide

Questions?

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Purpose

Antifungal

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