Your browser does not support JavaScript! MICONAZOLE NITRATE CREAM [REBEL DISTRIBUTORS CORP]
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MICONAZOLE NITRATE cream
[Rebel Distributors Corp]


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

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 2%
MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
1NDC:42254-319-301 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/FEIBusiness Operations
PSS World Medical, Inc.791528623REPACK(42254-319)
Establishment
NameAddressID/FEIBusiness Operations
STAT RX USA LLC786036330REPACK(42254-319)
Establishment
NameAddressID/FEIBusiness Operations
Dispensing Solutions, Inc.066070785RELABEL(42254-319), REPACK(42254-319)
Establishment
NameAddressID/FEIBusiness Operations
SCRIPT PAK964420108RELABEL(42254-319), REPACK(42254-319)
Establishment
NameAddressID/FEIBusiness Operations
Keltman Pharmaceuticals, Inc.362861077REPACK(42254-319)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distirbutors Corp.118802834RELABEL(42254-319), REPACK(42254-319)

Revised: 10/2012
 
Rebel Distributors Corp

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