Label: 3M CAVILON ANTIFUNGAL- miconazole nitrate cream
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- NDC Code(s): 17518-857-02, 17518-857-05
- Packager: 3M Health Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 12, 2019
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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Indications
◾Proven clinically effective in the treatment of most athlete's foot (tinea pedis), 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 -
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
- For the prevention of athlete's foot: If irritation occurs, discontinue use and consult a doctor
- Do not use for diaper rash
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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
- Inactive ingredients
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Principal Display Panel – Tube Label
LOT EXP
3M NDC 17518-857-02
Cavilon™
Antifungal Cream
Miconazole Nitrate 2%
- For effective relief of redness, irritation, scaling, itching, discomfort and burning
- Enriched with water-repelling ingredients
REF
3389Latex–Free
Net Weight 2 oz. • 56 g
Made in U.S.A with globally sourced materials for
3M Health Care
2510 Conway Ave.
St. Paul, MN 55144-10001-800-228-3957 3M.com/Cavilon3M and Cavilon are trademarks of 3M.
© 2013, 3M. All rights reserved.34-8712-8872-5
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INGREDIENTS AND APPEARANCE
3M CAVILON ANTIFUNGAL
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17518-857 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 1000 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALLANTOIN (UNII: 344S277G0Z) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM CHLORIDE (UNII: 451W47IQ8X) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) PROPYLPARABEN (UNII: Z8IX2SC1OH) WHITE WAX (UNII: 7G1J5DA97F) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) ZINC OXIDE (UNII: SOI2LOH54Z) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17518-857-02 24 in 1 CASE 11/30/2010 1 56 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:17518-857-05 12 in 1 CASE 11/30/2010 2 141 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 11/30/2010 Labeler - 3M Health Care (006173082) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 manufacture(17518-857)