KAISER PERMANENTE MICONAZOLE NITRATE- miconazole nitrate cream 
Kaiser Foundation Hospitals

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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Kaiser Permanente ®

Miconazole Nitrate

Drug Facts

Active ingredient

Miconazole nitrate USP 2%

Purpose

Antifungal

Uses

  • effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of itching, scaling, burning and discomfort that can accompany these conditions.

Warnings

For external use only

Do not use on children less than 2 years of age unless directed by a doctor

When using this product avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • condition persists
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • 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
  • not effective on the scalp or nails

Other information

  • To open: unscrew cap, use pointed end on cap to puncture seal
  • store at 20° - 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

Questions?

Call 1-866-923-4914

Manufactured by
Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1

Distributed by
Kaiser Foundation Hospitals
Livermore, CA 94551-9756

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

KAISER PERMANENTE®

Miconazole Nitrate Cream USP, 2%

ANTIFUNGAL CREAM
CURES MOST ATHLETE'S FOOT

* Compare to the active ingredient in Micatin®

NET WT 1 OZ (30 g)

Principal Display Panel - 30 g Tube Carton
KAISER PERMANENTE  MICONAZOLE NITRATE
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0179-8017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0179-8017-301 in 1 CARTON10/01/199105/31/2021
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/01/199105/31/2021
Labeler - Kaiser Foundation Hospitals (053052619)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295manufacture(0179-8017)

Revised: 11/2018
Document Id: 7ad200db-c8fa-f509-e053-2991aa0a9561
Set id: 3cc93bf1-7208-4152-b6d4-c77686d5206c
Version: 3
Effective Time: 20181116
 
Kaiser Foundation Hospitals