MEDLINE- miconazole nitrate cream 
Medline Industries, LP

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147 Remedy Clinical Antifungal Cream

Active ingredient

Miconazole nitrate 2.0% w/v

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use

  • on children under 2 years of age unless directed by doctor

When using this product

  • avoid contact with the eyes

Stop use and ask a doctor

  • if irritation occurs
  • there is no improvement within 4 weeks for athlete’s foot and ringworm
  • there is no improvement within 2 weeks for jock itch

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, vanillin, water, zea mays oil

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and foreign materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC092604

V1 RL22WAS

Package Label

Label V1 RL22WAS

MEDLINE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-147
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCINE (UNII: TE7660XO1C)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
PROPANEDIOL (UNII: 5965N8W85T)  
APRICOT KERNEL OIL PEG-6 ESTERS (UNII: DRG3KJZ1TJ)  
SOYBEAN OIL (UNII: 241ATL177A)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
WATER (UNII: 059QF0KO0R)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
PEG-32 STEARATE (UNII: 33GX5WQC0M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROLINE (UNII: 9DLQ4CIU6V)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PEG-6 STEARATE (UNII: 8LQC57C6B0)  
TROLAMINE (UNII: 9O3K93S3TK)  
TAURINE (UNII: 1EQV5MLY3D)  
ORANGE OIL (UNII: AKN3KSD11B)  
MANDARIN OIL (UNII: NJO720F72R)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
HYDROXYTYROSOL (UNII: QEU0NE4O90)  
CORN OIL (UNII: 8470G57WFM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-147-44118 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00508/01/2023
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 12/2023
Document Id: 0d997d1d-8664-201f-e063-6394a90a285e
Set id: 0d997d1d-8663-201f-e063-6394a90a285e
Version: 1
Effective Time: 20231228
 
Medline Industries, LP