3M CAVILON ANTIFUNGAL- miconazole nitrate cream 
3M Health Care

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.

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3M Cavilon™
Antifungal Cream

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 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

Inactive ingredients

Principal Display Panel – Tube Label

LOT   EXP

3M NDC 17518-857-02

Cavilon™

Antifungal Cream

Miconazole Nitrate 2%

REF
3389

Latex–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/Cavilon

3M and Cavilon are trademarks of 3M.
© 2013, 3M. All rights reserved.

34-8712-8872-5

Principal Display Panel – Tube Label

3M CAVILON ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17518-857
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17518-857-0224 in 1 CASE11/30/2010
156 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:17518-857-0512 in 1 CASE11/30/2010
2141 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C11/30/2010
Labeler - 3M Health Care (006173082)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO, LLC080170933manufacture(17518-857)

Revised: 6/2019
Document Id: ec6fa53b-6f28-444f-9fba-f078c156c139
Set id: a8a0896c-2b05-4c73-880a-4815955f2d32
Version: 4
Effective Time: 20190612
 
3M Health Care