Label: MICONAZOLE NITRATE- miconazole nitrate cream
- NDC Code(s): 42254-319-30
- Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0603-7805
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated October 2, 2012
If you are a consumer or patient please visit this version.
- Active ingredient
Miconazole nitrate 2%Close
- 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
- For external use only
- Do not use
on children under 2 years of age unless directed by a doctorClose
- When using this product
avoid contact with the eyesClose
- 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.Close
- 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.Close
- 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.Close
- Inactive ingredients
benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified waterClose
- SPL UNCLASSIFIED SECTION
Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811
Rev. 10/09 R2
Rebel Distributors Corp.
Thousand Oaks, CA 91320
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
miconazole nitrate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42254-319(NDC:0603-7805) Route of Administration TOPICAL 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 BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) MINERAL OIL (UNII: T5L8T28FGP) PEG-5 OLEATE (UNII: 0240V77G50) PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42254-319-30 1 in 1 CARTON 1 28.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 09/01/2003 Labeler - Rebel Distributors Corp (118802834) Registrant - PSS World Medical, Inc. (101822862) Establishment Name Address ID/FEI Business Operations PSS World Medical, Inc. 791528623 REPACK(42254-319) Establishment Name Address ID/FEI Business Operations STAT RX USA LLC 786036330 REPACK(42254-319) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 RELABEL(42254-319) , REPACK(42254-319) Establishment Name Address ID/FEI Business Operations SCRIPT PAK 964420108 RELABEL(42254-319) , REPACK(42254-319) Establishment Name Address ID/FEI Business Operations Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-319) Establishment Name Address ID/FEI Business Operations Rebel Distirbutors Corp. 118802834 RELABEL(42254-319) , REPACK(42254-319)