REMEDY ANTIFUNGAL- miconazole nitrate powder 
Medline Industries, LP

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.

----------

169 Remedy with Phytoplex Antifungal Clear Ointment

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use

  • on children under 2 years of age unless directed by a doctor
  • avoid contact with 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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control center right away.

Directions

Other Information

Inactive ingredients

Aphanizomenon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Leaf

Extract, Caprylic/Capric Triglycerides, 7-Dehydrocholesterol, Dipotassium Glycyrrhizate, Ethylene Brassylate, Eugenia Caryophyllus (Clove) Flower Extract, Glycerin, Hydrolyzed Soy Protein, Isopropyl Myristate, Methyldihydrojasmonate, Phospholipids, Silica, Sodium Benzoate, Tapioca Starch, Tocopheryl (Vitamin E) Acetate, Vanilla Plantifolia Fruit Extract, Water, Yeast Ferment Extract, Zea Mays (Corn) Oil, Zea Mays (Corn) Starch

Principal Display Panel

Label 169

REMEDY ANTIFUNGAL 
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-169
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
APHANIZOMENON FLOS-AQUAE (UNII: 49VG1X560X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
CLOVE (UNII: K48IKT5321)  
GLYCERIN (UNII: PDC6A3C0OX)  
SOY PROTEIN (UNII: R44IWB3RN5)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VANILLA (UNII: Q74T35078H)  
WATER (UNII: 059QF0KO0R)  
YEAST (UNII: 3NY3SM6B8U)  
CORN OIL (UNII: 8470G57WFM)  
STARCH, CORN (UNII: O8232NY3SJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-169-7985 g in 1 BOTTLE; Type 0: Not a Combination Product11/19/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00511/19/2012
Labeler - Medline Industries, LP (025460908)

Revised: 12/2022
Document Id: efcfbc69-31f3-445f-e053-2a95a90ab1da
Set id: 021b4a31-d7f6-4921-b4b1-cbe832eecd93
Version: 5
Effective Time: 20221214
 
Medline Industries, LP