SPL v4
SPL
SPL Set ID de4f703c-39e9-855e-e053-2a95a90a6ea9
Route
TOPICAL
Published
Effective Date 2022-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Chloroxylenol Imidurea Microcrystalline Cellulose Tricalcium Phosphate Allantoin Starch, Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-01

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%

Uses
  • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • For the treatment of most superficial skin infections caused by yeast (candida albicans)
  • Relieves most 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 layer of power over affected area twice a day (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 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.
Do Not Use
  • on children under 2 years of age unless directed by a doctor
  • avoid contact with the eyes
  • for athlete's foot and ringworm- if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor
  • for jock itch - if irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor
Active Ingredient

Miconazole Nitrate 2%

Other Information
  • Protect from freezing. Avoid excessive heat.
  • Do not use if package is damaged
Inactive Ingredients

Allantoin, Chloroxylenol, fragrance, Imidazolidinyl Urea, Microcrystalline Cellulose, Tricalcium Phosphate, Corn starch.

Manufactured For/ Distributed By:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 04/22 DV

Principal Display Panel

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)
  • For the treatment of most superficial skin infections caused by yeast (candida albicans)
  • Relieves most 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 layer of power over affected area twice a day (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 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.
Do Not Use (Do not use)
  • on children under 2 years of age unless directed by a doctor
  • avoid contact with the eyes
  • for athlete's foot and ringworm- if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor
  • for jock itch - if irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor
Active Ingredient (Active ingredient)

Miconazole Nitrate 2%

Other Information
  • Protect from freezing. Avoid excessive heat.
  • Do not use if package is damaged
Inactive Ingredients (Inactive ingredients)

Allantoin, Chloroxylenol, fragrance, Imidazolidinyl Urea, Microcrystalline Cellulose, Tricalcium Phosphate, Corn starch.

Manufactured For/ Distributed By:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 04/22 DV

Principal Display Panel

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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