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Miconole

Option Labs
Option Labs

Miconole


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Miconole 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

  • 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

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

Miconole

Miconazole Nitrate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:43645-112
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE MICONAZOLE 20 mg

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
ALLANTOIN
CETYL ALCOHOL
GLYCERIN
GLYCERYL MONOSTEARATE
ISOPROPYL MYRISTATE
METHYLPARABEN
polysorbate 80
propylene glycol
PROPYLPARABEN
water
SODIUM HYDROXIDE
STEARIC ACID

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 42.5 in 1 TUBE
2 NDC:43645-112-45 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2013-10-15


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