![3M CAVILON ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [3M HEALTH CARE]](https://medic.hrt.org//dailymed/images/a8a0896c-2b05-4c73-880a-4815955f2d32/cav01-0001-01.jpg)
| NDC | 17518-857-02, 17518-857-05 |
| Set ID | a8a0896c-2b05-4c73-880a-4815955f2d32 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | 3M Health Care |
| Generic Name | |
| Product Class | Azole Antifungal |
| Product Number | |
| Application Number | PART333C |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
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
-
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
-
Principal Display Panel – Tube Label
LOT EXP
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
REF
3389Latex–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/Cavilon3M and Cavilon are trademarks of 3M.
© 2013, 3M. All rights reserved.34-8712-8872-5
-
INGREDIENTS AND APPEARANCE
3M CAVILON ANTIFUNGAL
miconazole nitrate creamProduct 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)