REMEDY ANTIFUNGAL WITH OLIVAMINE- miconazole nitrate cream 
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.

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162 Antifungal

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Use

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

Keep out of reach of children.

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

Directions

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.

Medline Remedy is a registered trademark of Medline Industries, Inc. Olivamine is a registered trademark of McCord Research, Inc. Manufactured in USA for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA.
www.medline.com 1-800-MEDLINE RJ18WAR

Principal Display Panel - Remedy

Label 118 mL

REMEDY ANTIFUNGAL  WITH OLIVAMINE
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-162
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-162-04113 g in 1 TUBE; Type 0: Not a Combination Product01/01/200707/26/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/200707/26/2024
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 10/2022
Document Id: ebe29642-7bcd-2879-e053-2a95a90a961c
Set id: 28c5183e-05b4-1754-e054-00144ff8d46c
Version: 5
Effective Time: 20221025
 
Medline Industries, LP