3M CAVILON ANTIFUNGAL- miconazole nitrate cream

3M Cavilon Antifungal by

Drug Labeling and Warnings

3M Cavilon Antifungal by is a Otc medication manufactured, distributed, or labeled by 3M Health Care, Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

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

• Keep out of the reach of children
• If swallow, get medical help or contact a Poison Control Center right away

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

• 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

Principal Display Panel

LOT

NDC: 17518-857-02

3M Cavilon™

Antifungal Cream

Miconazole Nitrate 2%

• For effective relief of redness, irritation, scaling, itching, discomfort and burning
• Enriched with water-repelling ingredients

REF

3389

Latex-Free

Net Weight 2 oz. 56 g

Not Made With Natural Rubber Latex

Made in U.S.A. with globally sourced materials for

3M Health Care

2510 Conway Ave.

St. Paul, MN 55144

1-800-228-3957 3M.com/Cavilon

3M and Cavilon are trademarks of 3M.

© 2019, 3M. All right reserved.

34-8724-0627-6

INGREDIENTS AND APPEARANCE

3M CAVILON ANTIFUNGAL 
miconazole nitrate cream

Product 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)