Your browser does not support JavaScript! SUNMARK ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [MCKESSON]
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RxNorm Names

SUNMARK ANTIFUNGAL (miconazole nitrate) cream
[McKesson]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort

Warnings

For external use only

Ask a doctor before use

  • on children under 2 years of age

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

  • 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; change shoes and socks at least once daily

Other information

  • To open: unscrew cap, use pointed end on cap to puncture seal
  • store at room temperature
  • 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 McKesson One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

sunmark

antifungal cream

Miconazole Nitrate 2%
CURES MOST ATHLETE'S FOOT

NET WT 1 OZ (30 g)

Principal Display Panel - 30 g Tube Carton
SUNMARK   ANTIFUNGAL
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-689
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
apricot kernel oil 
benzoic acid 
butylated hydroxytoluene 
glycol stearate 
mineral oil 
polyethylene glycol 300 
water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-689-721 in 1 CARTON
130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C10/01/1991
Labeler - McKesson (177667227)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(49348-689)

Revised: 2/2013
 
McKesson

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