Miconazole Nitrate by Rebel Distributors Corp
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%
- 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
on children under 2 years of age unless directed by a doctor
avoid contact with the eyes
- 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)
If swallowed, get medical help or contact a Poison Control Center right away.
- 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.
- 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.
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
Rebel Distributors Corp.
Thousand Oaks, CA 91320
miconazole nitrate cream
|Labeler - Rebel Distributors Corp (118802834)|
|Registrant - PSS World Medical, Inc. (101822862)|
|PSS World Medical, Inc.||791528623||REPACK(42254-319)|
|STAT RX USA LLC||786036330||REPACK(42254-319)|
|Dispensing Solutions, Inc.||066070785||RELABEL(42254-319), REPACK(42254-319)|
|SCRIPT PAK||964420108||RELABEL(42254-319), REPACK(42254-319)|
|Keltman Pharmaceuticals, Inc.||362861077||REPACK(42254-319)|
|Rebel Distirbutors Corp.||118802834||RELABEL(42254-319), REPACK(42254-319)|