NDC | 50382-050-01 |
Set ID | 853f5d10-99c3-4fdc-87b9-0ee6826e84ad |
Category | HUMAN OTC DRUG LABEL |
Packager | Galentic Pharma (India) Priva Te Limited |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- 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.
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Warnings
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.
- Directions
- Other information.
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Directions
- 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
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INGREDIENTS AND APPEARANCE
MICONAZOLE
antifungal creamProduct 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)