Label: ALOE VESTA- miconazole nitrate ointment
- NDC Code(s): 53329-774-14, 53329-774-64
- Packager: Medline Industries, LP
- 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 August 8, 2023
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- 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 albicans
- Warnings
-
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: pay close attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
- 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 doctor
- this product is not effective on the scalp or nails
- Inactive ingredients
- Manufacturing Information
- Package Label
-
INGREDIENTS AND APPEARANCE
ALOE VESTA
miconazole nitrate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-774 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) MINERAL OIL (UNII: T5L8T28FGP) BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) WHITE PETROLATUM (UNII: B6E5W8RQJ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-774-14 56 g in 1 TUBE; Type 0: Not a Combination Product 09/30/2020 2 NDC:53329-774-64 141 g in 1 TUBE; Type 0: Not a Combination Product 09/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M005 09/30/2020 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)