1. Home
  2. Labeler Index
  3. Swiss-american Cdmo, Llc
  4. 60232-0046
  5. Label Information: Private Label Antifungal Barrier Cream

FDA Label for Private Label Antifungal Barrier Cream

View Indications, Usage & Precautions

Table of Contents

    1. WARNINGS
    2. ACTIVE INGREDIENTS
    3. INDICATIONS & USES
    4. DIRECTIONS
    5. KEEP OUT OF REACH OF CHILDREN
    6. INACTIVE INGREDIENTS
    7. QUESTIONS?
    8. PURPOSE
    9. LABELING

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 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?



Call toll free 1-866-416-2366


Purpose



Antifungal


* Please review the disclaimer below.