Search by Drug Name or NDC

NDC 17518-0857-05 3M Cavilon Antifungal 2 g/1000g Details

3M Cavilon Antifungal 2 g/1000g

3M Cavilon Antifungal is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by 3M Company. The primary component is MICONAZOLE NITRATE.

Product Information

NDC	17518-0857
Product ID	17518-857_4bcbbfd7-65cd-4296-a4eb-1b1f466dcee6
Associated GPIs	90154050103705
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	3M Cavilon Antifungal
Proprietary Name Suffix	n/a
Non-Proprietary Name	miconazole nitrate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	2
Active Ingredient Units	g/1000g
Substance Name	MICONAZOLE NITRATE
Labeler Name	3M Company
Pharmaceutical Class	Azole Antifungal [EPC], Azoles [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333C
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17518-0857-05 (17518085705)

Pricing Information	N/A
NDC Package Code	17518-857-05
Billing NDC	17518085705
Package	12 TUBE in 1 CASE (17518-857-05) / 141 g in 1 TUBE
Marketing Start Date	2010-11-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a8a0896c-2b05-4c73-880a-4815955f2d32 Details

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.

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
miconazole nitrate (UNII: VW4H1CYW1K) (miconazole - UNII:7NNO0D7S5M)	miconazole nitrate	2 g in 1000 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	11/30/2010

Labeler - 3M Company (006173082)

Name	Address	ID/FEI	Business Operations
Establishment
Swiss-American CDMO, LLC		080170933	MANUFACTURE(17518-857)

Revised: 6/2020

Document Id: 4bcbbfd7-65cd-4296-a4eb-1b1f466dcee6

Set id: a8a0896c-2b05-4c73-880a-4815955f2d32

Version: 6

Effective Time: 20200630