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Miconazole Nitrate by Rebel Distributors Corp

Medically reviewed on Oct 2, 2018

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: Rebel Distributors Corp
NDC Code: 42254-319

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.

Miconazole Nitrate 2% Cream

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, scaling, cracking, burning and discomfort associated with those conditions

Warnings

For external use only

Do not use

on children under 2 years of age unless directed by a doctor

When using this product

avoid contact with the eyes

Stop use and ask a doctor if
  • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)
  • irritation occurs or if there is no improvement 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
  • 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:

  • use daily for 4 weeks. If condition persists longer, consult a doctor.
  • pay special attention to the spaces between the toes
  • wear well-fitting, ventilated shoes
  • change shoes and socks at least once daily

For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on the scalp or nails.

Other information
  • store at 15° - 30°C (59° - 86°F)
  • lot number and expiration date: see crimp of tube or see box
  • to open: unscrew cap, use pointed end on cap to puncture seal

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 10/09 R2
8280719 7805

Repackaged by
Rebel Distributors Corp.
Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-319(NDC:0603-7805)
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
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
MINERAL OIL 
PEG-5 OLEATE 
PEGOXOL 7 STEARATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:42254-319-301 TUBE in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/01/2003
Labeler - Rebel Distributors Corp (118802834)
Registrant - PSS World Medical, Inc. (101822862)
Establishment
NameAddressID/FEIOperations
PSS World Medical, Inc.791528623REPACK(42254-319)
Establishment
NameAddressID/FEIOperations
STAT RX USA LLC786036330REPACK(42254-319)
Establishment
NameAddressID/FEIOperations
Dispensing Solutions, Inc.066070785RELABEL(42254-319), REPACK(42254-319)
Establishment
NameAddressID/FEIOperations
SCRIPT PAK964420108RELABEL(42254-319), REPACK(42254-319)
Establishment
NameAddressID/FEIOperations
Keltman Pharmaceuticals, Inc.362861077REPACK(42254-319)
Establishment
NameAddressID/FEIOperations
Rebel Distirbutors Corp.118802834RELABEL(42254-319), REPACK(42254-319)

 
Rebel Distributors Corp

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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