Label: MICONAZOLE- antifungal cream
Contains inactivated NDC Code(s)
NDC Code(s): 50382-050-01
- Packager: Galentic Pharma (India) Priva Te Limited
- 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 July 23, 2013
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- Active Ingredient
Uses - Antifungal
- For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
- For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
- Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
Do not use:
- Do not use on children under 2 years of age unless directed by a doctor.
- Avoid contact with eyes.
- For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
- For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- Other information.
- Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a doctor.
- Foe athlete's foot and ringworm, use daily for 4 weeks.
- For jock itch, use daily for 2 weeks.
- For athlete's foot, pay special attention to spaces between toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
- Inactive Ingredients
- Keep Out of Reach of Children
- Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-050 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 CETETH-20 (UNII: I835H2IHHX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLOROCRESOL (UNII: 36W53O7109) LIGHT MINERAL OIL (UNII: N6K5787QVP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-050-01 72 in 1 CASE 1 1 in 1 BOX 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 07/18/2013 Labeler - Galentic Pharma (India) Priva Te Limited (918531450)