Miconole
FDA Label NDC 43645-112

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Option Labs for the product Miconole (NDC 43645-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, other ingredients:, uses, warnings, otc - do not use, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Miconazole Nitrate 2%

Aloe Vera Polysaccharide 1%

Purpose

Antifungal

Other Ingredients:

Allantoin, Cetyl Alcohol, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water, Sodium Hydroxide, Stearic Acid, Fragrance

Uses

for the treatment of

  • athletes foot (tinea pedis)
  • jock itch (tinea cruris)
  • ringworm (tinea corporis)
  • superficial skin infections caused by yeast (candida albicans)

Warnings

for external use only

Otc - Do Not Use

  • do not use on children under 2 years of age unless directed by a doctor
  • avoid contact with eyes
  • If irritation occurs or if there is no improvement within 2 weeks, discontinue use and see a doctor

Keep Out Of Reach Of Children.

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

Directions

  • wash the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for ringworm use daily for 4 weeks, if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails.

Other Information

Store at 20°C - 25°C (68°F - 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).  See USP Controlled Room Temperature.

Comments

You may report side effects to FDA at 1-800-FDA-1088

Principal Display Panel

Miconole Label (Mm1)

Miconole Label (Mm1)

NDC 43645-112-45

Manufactured for:

Option Labs.

801 Noble St., 8th Floor Commerce Tower

Anniston, AL 36201

Miconole

(miconazole nitrate 2%) Cream

with Aloe Vera (proprietary patented

polysaccharides from heart of aloe)

Net Wt. 1.5 oz.

Rev. 02/13

* Please review the disclaimer below.