147 Remedy Clinical Antifungal Cream

147 Remedy Clinical Antifungal Cream
SPL v2
SPL
SPL Set ID 0d997d1d-8663-201f-e063-6394a90a285e
Route
TOPICAL
Published
Effective Date 2023-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Glycine Pyridoxine Hydrochloride Glycol Stearate Olive Oil Polysorbate 20 Methylparaben Dimethyl Sulfone Niacinamide Citrus Maxima Fruit Rind Oil Tocopherol Cholecalciferol Ascorbyl Palmitate Propanediol Apricot Kernel Oil Peg-6 Esters Soybean Oil Polyisobutylene (1000 Mw) Sorbitan Isostearate Propylene Glycol Diazolidinyl Urea Propylparaben Silicon Dioxide Cetyl Dimethicone 150 Water Vitamin A Palmitate Acetylcysteine Peg-32 Stearate Citric Acid Monohydrate Proline Ethyl Vanillin Aloe Vera Leaf Polyethylene Glycol 400 Peg-6 Stearate Trolamine Taurine Orange Oil Mandarin Oil Ascorbic Acid Hydroxytyrosol Corn Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-01

Description

Miconazole nitrate 2.0% w/w

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole nitrate 2.0% w/w

Uses
  • for the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) or ringworm (tinea corporis)
  • relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Warnings

For external use only

Directions
  • clean the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily or as directed by a physician
  • supervise use by children
  • 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 four weeks; for jock itch, use daily for two weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on scalp or nails

Do Not Use
  • on children under 2 years of age unless directed by doctor
Package Label

Active Ingredient

Miconazole nitrate 2.0% w/w

Other Information
  • protect from freezing
  • avoid excessive heat
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

When Using This Product
  • avoid contact with the eyes
Manufacturing Information

www.medline.com

©2022 Medline and Medline Remedy

are registered trademarks of

Medline Industries, LP.

Made in USA of foreign and domestic materials

Manufactured for Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE

REF: MSC092604

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.


Structured Label Content

Uses
  • for the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris) or ringworm (tinea corporis)
  • relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Purpose

Antifungal

Warnings

For external use only

Directions
  • clean the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily or as directed by a physician
  • supervise use by children
  • 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 four weeks; for jock itch, use daily for two weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on scalp or nails

Do Not Use (Do not use)
  • on children under 2 years of age unless directed by doctor
Package Label

Active Ingredient (Active ingredient)

Miconazole nitrate 2.0% w/w

Other Information (Other information)
  • protect from freezing
  • avoid excessive heat
Inactive Ingredients (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

When Using This Product (When using this product)
  • avoid contact with the eyes
Manufacturing Information

www.medline.com

©2022 Medline and Medline Remedy

are registered trademarks of

Medline Industries, LP.

Made in USA of foreign and domestic materials

Manufactured for Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE

REF: MSC092604

Stop Use and Ask A Doctor (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. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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