Label: REMEDY ANTIFUNGAL WITH OLIVAMINE- miconazole nitrate cream
- NDC Code(s): 53329-162-04
- 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 October 25, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
-
Use
- For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), 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.
-
Warnings
For external use only
Do not use
- on children under 2 years of age unless directed by a doctor
- avoid contact with the eyes
- for athlete's 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 2 weeks, discontinue use and consult a doctor
-
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.
- 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 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.
- Other information
-
Inactive ingredients
acrylamide/ammonium acrylate copolymer, aloe barbadensis leaf juice, apricot kernel oil peg-6 esters, ascorbic acid, ascorbyl palmitate, cetyl dimethicone, cholecalciferol, citric acid, citrus aurantium dulcis (orange) peel oil, citrus grandis (grapefruit) peel oil, citrus tangerina (tangerine) peel oil, diazolidinyl urea, ethyl vanillin, glycine, glycine soja (soybean) oil, glycol stearate, hydroxytyrosol, l-proline, l-taurine, methylparaben, methylsulfonylmethane, n-acetyl-l-cysteine, niacinamide, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, peg-6 stearate, peg-8, peg-32 stearate, polyisobutene, polysorbate-20, propanediol, propylene glycol, propylparaben, pyridoxine hcl, retinyl palmitate, silica, tocopherol, triethanolamine, water.
- SPL UNCLASSIFIED SECTION
- Principal Display Panel - Remedy
-
INGREDIENTS AND APPEARANCE
REMEDY ANTIFUNGAL WITH OLIVAMINE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-162 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 TROLAMINE (UNII: 9O3K93S3TK) PROPANEDIOL (UNII: 5965N8W85T) VANILLIN (UNII: CHI530446X) WATER (UNII: 059QF0KO0R) CORN OIL (UNII: 8470G57WFM) TAURINE (UNII: 1EQV5MLY3D) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PEG-6 STEARATE (UNII: 8LQC57C6B0) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) MANDARIN OIL (UNII: NJO720F72R) HYDROXYTYROSOL (UNII: QEU0NE4O90) APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ) ORANGE OIL (UNII: AKN3KSD11B) PROLINE (UNII: 9DLQ4CIU6V) ACETYLCYSTEINE (UNII: WYQ7N0BPYC) PEG-32 STEARATE (UNII: 33GX5WQC0M) ALOE VERA LEAF (UNII: ZY81Z83H0X) ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) CHOLECALCIFEROL (UNII: 1C6V77QF41) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCINE (UNII: TE7660XO1C) SOYBEAN OIL (UNII: 241ATL177A) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) GLYCOL STEARATE (UNII: 0324G66D0E) METHYLPARABEN (UNII: A2I8C7HI9T) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) NIACINAMIDE (UNII: 25X51I8RD4) OLIVE OIL (UNII: 6UYK2W1W1E) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-162-04 113 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2007 07/26/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/01/2007 07/26/2024 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)
