067 Remedy with Phytoplex Antifungal Ointment

Manufacturer
Medline Industries Inc.
Effective date
2019-12-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 23:49:45

Label at a glance#

ProductRemedy with Phytoplex Antifungal Clear
Active ingredientMICONAZOLE NITRATE
Label structure8 sections

Indications and uses

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.

Dosage and administration

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 shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use...

Storage and handling

Protect from freezing. Avoid excessive heat.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2.0%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For External Use Only.

Do not use

OTC - DO NOT USE SECTION

  • on children under 2 years of age unless directed by a doctor
  • on scalp or nails

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 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.

Other information

STORAGE AND HANDLING SECTION

  • Protect from freezing. Avoid excessive heat.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aphanizomemnon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Extract, Carboxymethyl Cellulose, Carthamus Tinctorius (Safflower) Seed Oil, Dimethicone, Eugenia Caryophyllus (Clove) Flower Extract, Glycine Soja (Soybean) Oil, Olea Europaea Fruit (Olive) Oil, Petrolatum, Zea Mays (Corn) Oil

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53329-167-10

MEDLINE

REMEDY®

PHYTOPLEX®

Botanical Nutrition for Sensitive Skin

Treatment

Antifungal Ointment

Miconazole Nitrate 2%

Helps treat and relieve itching

& burning with a fungal infection

CHG Compatible

Paraben Free

Hypoallergenic

Net Wt 2.5 oz (71 g)

labellabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-167-10GM - Gram53329-167ad1dcec6-0f57-4c85-b70b-ecac287e44a812015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1K3
MICONAZOLEACTIVE MOIETY7NNO0D7S5M3
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19X3
CLOVEINACTIVE INGREDIENTK48IKT53213
CORN OILINACTIVE INGREDIENT8470G57WFM3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O3
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B03
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U3
SAFFLOWER OILINACTIVE INGREDIENT65UEH262IS3
SOYBEAN OILINACTIVE INGREDIENT241ATL177A3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-16753329-167-10, 53329-167-16, 53329-167-96

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 50 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XCAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
8 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
8 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET / ORAL20 mgExact identifier — unii candidate
11 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XTABLET / ORAL45 mgExact identifier — unii candidate
8 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCAPSULE / ORAL918 mgExact identifier — unii candidate
11 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177ASOLUTION / TOPICAL5.82 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
8 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMSUSPENSION / ORAL2.5 ml/5mlExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii candidate
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177ACAPSULE / ORAL1318 mgExact identifier — unii candidate
7 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XDROPS / ORAL10 mg/1mlExact identifier — unii candidate
8 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS223 mgExact identifier — unii candidate
7 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XINJECTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
8 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AAEROSOL, FOAM / TOPICAL50 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET / SUBLINGUAL1.7 mgExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XJELLY / VAGINALNAExact identifier — unii candidate
8 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, DELAYED RELEASE / ORAL0.03 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMCREAM / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
CORN OILCORN OIL8470G57WFMTABLET, COATED / ORAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
CARBOXYMETHYLCELLULOSECARBOXYMETHYLCELLULOSE05JZI7B19XSUSPENSION / ORAL50.07 mg/5mlExact identifier — unii candidate
8 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SOYBEAN OILSOYBEAN OIL241ATL177AINJECTION, EMULSION / INTRAVENOUS107100 mgExact identifier — unii candidate
7 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9ff9c935-84cc-0610-e053-2995a90a7fabce16b0c5-a0de-423e-a8f5-3d75d85dd3222020-03-03WarningsExact identifier
spl set id: ce16b0c5-a0de-423e-a8f5-3d75d85dd322

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.