Label: MICONAZOLE NITRATE cream
-
Contains inactivated NDC Code(s)
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
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.
Drug Label Information
Updated October 2, 2012
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- For external use only
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate creamProduct 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)