MICONAZOLE NITRATE- miconazole nitrate cream 
Rugby Laboratories, Inc.

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Miconazole Nitrate Cream USP

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 useon children less than 2 years of age unless directed by a doctor

When using this productavoid 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

  • do not use if the seal on tube is punctured or not visible
  • 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

Distributed by: RUGBY LABORATORIES
17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Rugby

Antifungal Cream

Cures Most Athlete's Foot
Miconazole Nitrate

Cream USP, 2%
Antifungal Cream

NET WT 1 oz (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1134
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)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1134-281 in 1 CARTON05/19/201704/30/2023
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 DrugM00510/01/199104/30/2023
Labeler - Rugby Laboratories, Inc. (079246066)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharma Canada Inc.243339023manufacture(0536-1134)

Revised: 7/2025
 
Rugby Laboratories, Inc.