FDA Label for Private Label Antifungal Barrier Cream

View Indications, Usage & Precautions

Private Label Antifungal Barrier Cream Product Label

The following document was submitted to the FDA by the labeler of this product Swiss-american Cdmo, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Warnings



For external use only. Not intended for ingestion. Do not use on children under 2 years 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 treatment of jock itch: if irritation occurs or there is no improvement within 2 weeks discontinue use and consult a doctor. Do not use for diaper rash. Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away


Use And Directions



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

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


Active Ingredient



Miconazole Nitrate 2.00%


Inactive Ingredient



Allantoin, Beeswax, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Fragrance, Hydrogenated Castor Oil, Isopropyl Palmitate, Methylparaben, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Chloride, Zinc Oxide


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