Label: ANTI-FUNGAL- miconazole nitrate cream
- NDC Code(s): 52000-021-36, 52000-021-37
- Packager: Universal Distribution Center LLC
- 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 April 15, 2015
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- ACTIVE INGREDIENT
Miconazole Nitrate 2.0%Close
- INDICATIONS & USAGE
- cures most athlete's foot, jock itch, and ringworm.
- relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
Do not use on children under 2 years of age except under the advice and supervision of a doctor.
For external use only.Close
- WHEN USING
When using this product avoid contact with eyes.Close
- STOP USE
Stop using this product and ask a doctor
- irritation occurs
- there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch).
- do not use for diaper rash
- KEEP OUT OF REACH OF CHILDREN
Keep this and all drugs out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.Close
- DOSAGE & ADMINISTRATION
wash affected area and dry thoroughly
Apply a thin layer 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, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day
for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
if conditions persist longer, ask a doctor
this product is not effective on the scalp or nails.
- SPL UNCLASSIFIED SECTION
- Store between 15ºC to 30º C (59ºF to 86º F)
- Lot No. & Exp. Date: see crimp of tube.
- INACTIVE INGREDIENT
Benzoic Acid, Butylated Hydroxyanisole, Mineral Oil, PEGlicol-5-Oleate, Pegoxol-7 Stearate, Purified Water.Close
- PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
NET WT 0.5 OZ (14 g)
- INGREDIENTS AND APPEARANCE
miconazole nitrate cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 0.02 g 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:52000-021-37 1 in 1 BOX 1 NDC:52000-021-36 14 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 04/15/2015 Labeler - Universal Distribution Center LLC (019180459) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52000-021)