ANTIFUNGAL- miconazole nitrate cream 
Cardinal Health, 110 dba LEADER

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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Antifungal Cream

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

  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE
  • To open: unscrew cap, use pointed end on cap to puncture seal
  • store at 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water

Questions?

Call 1-866-923-4914

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Cures Most Athlete's Foot,
Jock Itch and Ringworm
Relieves Itching & Burning

Antifungal Cream
Miconazole Nitrate Cream USP, 2% | Antifungal

COMPARE TO MICATIN®
active ingredient*

100% Money Back Guarantee

NET WT 1 OZ (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
ANTIFUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0040
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
benzoic acid (UNII: 8SKN0B0MIM)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
glycol stearate (UNII: 0324G66D0E)  
mineral oil (UNII: T5L8T28FGP)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0040-11 in 1 CARTON02/12/202004/30/2023
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 FINALpart333C10/01/199104/30/2023
Labeler - Cardinal Health, 110 dba LEADER (063997360)

Revised: 1/2023
 
Cardinal Health, 110 dba LEADER