3M Cavilon Antifungal: Package Insert and Label Information

3M CAVILON ANTIFUNGAL- miconazole nitrate cream
3M Company

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 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

Principal Display Panel
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3M CAVILON ANTIFUNGAL
miconazole nitrate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC: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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC: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 NDC: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 Company (006173082)
Establishment
Name Address ID/FEI Operations
Swiss-American CDMO, LLC 080170933 MANUFACTURE (17518-857)

Revised: 06/2020 3M Company

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