218 Remedy Antifungal Cream With Zinc Oxide

218 Remedy Antifungal Cream With Zinc Oxide
SPL v3
SPL
SPL Set ID 1ea444eb-f2f5-8c63-e063-6294a90acac8
Route
TOPICAL
Published
Effective Date 2024-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Chlorocresol White Petrolatum Zinc Oxide Sodium Phosphate Dibasic Dihydrate Light Mineral Oil Polyoxyl 20 Cetostearyl Ether Edetate Disodium Propylene Glycol Water Sodium Phosphate, Monobasic, Dihydrate Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-01

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), 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 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 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.
  • Store at controlled room temperature.
Inactive Ingredients

cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, macrogol cetostearyl ether, propylene glycol, purified water, sodium phosphate dibasic dihydrate, sodium phosphate monobasic dihydrate, white petrolatum, zinc oxide.

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

www.medline.com ©2024 Medline and Medline Remedy are registered trademarks of Medline Industries, LP.

Made in India.

Manufactured for Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA.

1-800-MEDLINE

REF: MSC095635

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), 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 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 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.
  • Store at controlled room temperature.
Inactive Ingredients (Inactive ingredients)

cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, macrogol cetostearyl ether, propylene glycol, purified water, sodium phosphate dibasic dihydrate, sodium phosphate monobasic dihydrate, white petrolatum, zinc oxide.

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

www.medline.com ©2024 Medline and Medline Remedy are registered trademarks of Medline Industries, LP.

Made in India.

Manufactured for Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA.

1-800-MEDLINE

REF: MSC095635

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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