162 Antifungal Cream 2% Miconazole Nitrate

162 Antifungal Cream 2% Miconazole Nitrate
SPL v7
SPL
SPL Set ID 28c5183e-05b4-1754-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2024-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Cetyl Dimethicone 25 Sorbitan Isostearate Trolamine Corn Oil Polyisobutylene (1000 Mw) Cholecalciferol Pyridoxine Hydrochloride Tocopherol Hydroxytyrosol Propylene Glycol Taurine Niacinamide Polysorbate 20 Acrylamide Methylparaben Dimethyl Sulfone Propylparaben Vitamin A Palmitate Apricot Kernel Oil Peg-6 Esters Ethyl Vanillin Propanediol Aloe Vera Leaf Acetylcysteine Silicon Dioxide Water Ascorbic Acid Orange Oil Ascorbyl Palmitate Olive Oil Peg-32 Stearate Citric Acid Monohydrate Citrus Maxima Fruit Rind Oil Mandarin Oil Peg-6 Stearate Polyethylene Glycol 400 Diazolidinyl Urea Soybean Oil Proline Glycine Glycol Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-01-01

Description

Miconazole Nitrate 2.0% w/w

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2.0% w/w

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

Section 42229-5

Medline Remedy and Olivamine are registered trademarks of Medline Industries, LP. Manufactured in USA for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA.

www.medline.com 1-800-MEDLINE

Section 43683-2

update to directions to reflect current labeling.

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 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 four weeks; for jock itch, use daily for two weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
Do Not Use
  • on children under 2 years of age unless directed by a doctor
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, PEG-6 stearate, PEG-8, PEG-32 stearate, polyisobutene, polysorbate 20, propanediol, propylene glycol, propylparaben, pyridoxine HCI, retinyl palmitate, silica, sorbitan isostearate, tocopherol, triethanolamine, water, zea mays oil

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.

Principal Display Panel Remedy


Structured Label Content

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

Section 42229-5 (42229-5)

Medline Remedy and Olivamine are registered trademarks of Medline Industries, LP. Manufactured in USA for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA.

www.medline.com 1-800-MEDLINE

Section 43683-2 (43683-2)

update to directions to reflect current labeling.

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 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 four weeks; for jock itch, use daily for two weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
Do Not Use (Do not use)
  • on children under 2 years of age unless directed by a doctor
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, PEG-6 stearate, PEG-8, PEG-32 stearate, polyisobutene, polysorbate 20, propanediol, propylene glycol, propylparaben, pyridoxine HCI, retinyl palmitate, silica, sorbitan isostearate, tocopherol, triethanolamine, water, zea mays oil

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

Principal Display Panel Remedy (Principal Display Panel - Remedy)


Advanced Ingredient Data


Raw Label Data

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