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

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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 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 healthcare 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

Questions? 1-800-228-3957

Principal Display Panel – Tube Label

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

3389

Latex –Free

Net Weight 2 oz. • 56 g

Made in U.S.A for

3M Health Care

St. Paul, MN 55144-1000

1-800-228-3957

www.3M.com/Cavilon

© 2010, 3M. All rights reserved.

3M and Cavilon are trademarks of 3M.

34-8706-0175-3

3M CAVILON ANTIFUNGAL  miconazole nitrate   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 17518-857 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength miconazole nitrate (miconazole) miconazole nitrate 2 g  in 1000 g

Inactive Ingredients Ingredient Name Strength water   allantoin   edetate disodium   sodium chloride   methylparaben   propylene glycol   petrolatum   dimethicone   Propylparaben   white wax   Hydrogenated castor oil   zinc oxide   Isopropyl palmitate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17518-857-02 24 TUBE In 1 CASE contains a TUBE 1 56 g In 1 TUBE This package is contained within the CASE (17518-857-02) 2 17518-857-05 12 TUBE In 1 CASE contains a TUBE 2 141 g In 1 TUBE This package is contained within the CASE (17518-857-05)

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	Operations
Swiss American Products, Inc.		611921669	MANUFACTURE

Revised: 11/20103M Health Care