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Name:Bf-micozo
Manufacturer:Bright Future Pharmaceuticals Factory
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BF-MICOZO  - miconazole nitrate cream 
Bright Future Pharmaceuticals Factory

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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Drug Facts

Active Ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

Treats tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ring worm).

Relieves itching, burning, scaling and cracking which accompanies these conditions.

Warnings


For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

Avoid contact with the eyes

Keep this and all drugs out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For athlete's foot, ring worm and jock itch: Wash 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 or a health care professional.
  • For athlete's foot: Pay attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily. Use the drug daily for four weeks. If condition persists longer, consult a doctor.
  • For ring worm: Use the drug daily for four weeks. If condition persists longer, consult a doctor.
  • For jock itch: Use the drug daily for two weeks. If condition persists longer, consult a doctor.
          This product is not effective on the scalp or nails.

Stop use and consult a doctor

  • If irritation occurs or if there is no improvement within four weeks of treatment of athlete's foot.
  • If irritation occurs or if there is no improvement within two weeks of treatment of jock itch.

Other information

Store in a dry place at room temperature (250C). Do not use if seal on the tube is broken or shows evidence of being opened.

Inactive ingredients

Cetomacrogol Emulsifying Wax, Dimethyl Sulfoxide, Glycerin 99.5%, Phenoxyethanol, Purified Water, Span 80, Mineral Oil, White Petroleum Jelly

Questions or Comments?

(626)-287-4700 M-F 9am to 5pm PST

Bright Future                                      Net Wt. 15g(0.53oz)

BF MICOZO CREAM 2%

Active Ingredient: Miconazole Nitrate 2%

Antifungal

Relieves itching, burning, scaling and cracking

Image of Carton Label


BF-MICOZO 
miconazole nitrate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10884-2265
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE (Miconazole) MICONAZOLE NITRATE 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CETETH-20  
GLYCERIN  
MINERAL OIL  
PHENOXYETHANOL  
PETROLATUM  
DIMETHYL SULFOXIDE  
SORBITAN MONOOLEATE  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10884-2265-2 1 TUBE ( TUBE) in 1 BOX contains a TUBE (10884-2265-1)
1 NDC:10884-2265-1 15 g in 1 TUBE This package is contained within the BOX (10884-2265-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 03/08/2011

Labeler - Bright Future Pharmaceuticals Factory (663118677)
Establishment
Name Address ID/FEI Operations
Bright Future Pharmaceuticals Factory 663118677 manufacture

Revised: 03/2011 Bright Future Pharmaceuticals Factory



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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