171 Remedy with Phytoplex Antifungal Clear Ointment

Manufacturer
Medline Industries, LP
Effective date
2024-01-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:12:14

Label at a glance#

ProductRemedy with Phytoplex
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 ointment 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, ...

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 ointment 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

7-dehydrocholestrol, aphanizomenon flos-aquae (algae) extract, camellia sinensis (green tea) extract, caprylic/capric triglycerides, carboxymethyl cellulose, carthamus tinctorius (safflower) seed oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hydrolyzed soy protein, olea europaea fruit (olive) oil, petrolatum, phospholipids, tocopherol acetate, water, yeast ferment extract, zea mays (corn) oil

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53329-171-10

MEDLINE

REMEDY®

PHYTOPLEX®

Botanical Nutrition for Sensitive Skin

Treatment

Antifungal Ointment

Miconazole Nitrate 2%

Helps treat and relieve itching

& burning associated with a fungal infection

CHG Compatible

Paraben Free

Hypoallergenic

Net Wt 2.5 oz (71 g)

Tube labelTube label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-171REMEDY WITH PHYTOPLEX (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES, LP]5Legacy NDC20240130_3a5cda93-2606-65d4-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-171-10GM - Gram53329-171784fceae-297e-4eee-aa66-95f5168b485312020-01-03

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-17153329-171-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

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
10198f85-ea69-f655-e063-6294a90a3ce33a5cda93-2606-65d4-e054-00144ff8d46c2024-01-29WarningsExact identifier
spl id: 10198f85-ea69-f655-e063-6294a90a3ce3
spl set id: 3a5cda93-2606-65d4-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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