Drug Listing: Dermafungal

Drug Listing: Dermafungal
SPL v9
SPL
SPL Set ID 4e7739a1-cff0-4b76-94f0-d9f9af158df5
Route
TOPICAL
Published
Effective Date 2014-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (0.02 g)
Inactive Ingredients
Medium-chain Triglycerides Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Imidurea Dimethicone Edetate Disodium Glyceryl Monostearate Methylparaben Peg-40 Castor Oil Peg-100 Stearate Petrolatum Propylene Glycol Propylparaben Stearic Acid Water Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2005-12-12

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%

Uses:
  • For the treatment and prevention of most: athlete's foot, jock itch, ringworm
  • relieves itching, scaling,cracking, and discomfort associated with these conditions.
Purpose:

Antifungal

Warnings
  • Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.
Warnings:
  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Stop use and ask doctor if irritation occurs , condition worsens or does not improve in 2 weeks for jock itch, or within 4 weeks for athlete's foot and ringworm.
Directions

Cleanse affected area and dry thoroughly. Apply a thin layer to affected area twice daily or as directed by physician.

  • For jock itch use daily for two weeks.
  • For athelete's foot use daily for four weeks.
Active Ingredient:

Miconazole Nitrate 2%

Other Information:
  • This product is not effective on the scalp and nails.
  • Store at room temperature (59°-86°F)
Inactive Ingredients:

Caprylic/Capric Triglyceride, Ceteareth-20, Disodium EDTA, Glyceryl Stearate, Methylparaben, PEG-40 Castor Oil, PEG-100 Stearate, Petrolatum, Propylene Glycol, Propylparaben, Stearic Acid, Water, Xantham Gum

Durmafungal Principal Display Panel and Drug Facts


Structured Label Content

Uses:
  • For the treatment and prevention of most: athlete's foot, jock itch, ringworm
  • relieves itching, scaling,cracking, and discomfort associated with these conditions.
Purpose:

Antifungal

Warnings
  • Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.
Warnings:
  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Stop use and ask doctor if irritation occurs , condition worsens or does not improve in 2 weeks for jock itch, or within 4 weeks for athlete's foot and ringworm.
Directions

Cleanse affected area and dry thoroughly. Apply a thin layer to affected area twice daily or as directed by physician.

  • For jock itch use daily for two weeks.
  • For athelete's foot use daily for four weeks.
Active Ingredient:

Miconazole Nitrate 2%

Other Information:
  • This product is not effective on the scalp and nails.
  • Store at room temperature (59°-86°F)
Inactive Ingredients:

Caprylic/Capric Triglyceride, Ceteareth-20, Disodium EDTA, Glyceryl Stearate, Methylparaben, PEG-40 Castor Oil, PEG-100 Stearate, Petrolatum, Propylene Glycol, Propylparaben, Stearic Acid, Water, Xantham Gum

Durmafungal Principal Display Panel and Drug Facts


Advanced Ingredient Data


Raw Label Data

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