SUNMARK  ANTIFUNGAL- miconazole nitrate cream 
McKesson

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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sunmark
antifungal

Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

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.

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49348-689
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-689-72 1 in 1 CARTON
1 30 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333C 10/01/1991
Labeler - McKesson (177667227)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49348-689)

Revised: 2/2013
Document Id: 0155e13e-82d1-4620-85ef-ecd4aa925e41
Set id: 7c15d95a-5b89-4789-8c91-3f61d7ec7707
Version: 1
Effective Time: 20130204
 
McKesson