Label: ALOE VESTA ANTIFUNGAL- miconazole nitrate ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 43553-3251-2, 43553-3251-5 - Packager: ConvaTec, Inc.
- 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.
Drug Label Information
Updated April 8, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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Uses
- Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
- Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort that accompany these conditions.
- For the treatment of most superficial skin infections caused by yeast (Candida albicans).
- Follow a physician's instructions when treating Candida.
- Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
- Warnings
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Directions
Clean the affected area and dry thoroughly.
- Apply a thin layer of ointment over affected area twice daily (morning and night) or as directed by a physician.
- Supervise children in use of this product.
For athlete's foot and ringworm, use daily for 4 weeks.
For jock itch: use daily for 2 weeks
- If condition persists longer, consult a physician.
- This product is not effective on the scalp or nails.
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALOE VESTA ANTIFUNGAL
miconazole nitrate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43553-3251 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color white (white to off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43553-3251-2 56 g in 1 TUBE 2 NDC:43553-3251-5 141 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 10/03/1997 Labeler - ConvaTec, Inc. (947989757) Registrant - ConvaTec, Inc. (947989757) Establishment Name Address ID/FEI Business Operations Guest Packaging LLC 001773076 manufacture Establishment Name Address ID/FEI Business Operations Medicia 091396697 manufacture Establishment Name Address ID/FEI Business Operations ConvaTec, Inc. 947989757 analysis
