Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID c664e6c6-2a64-409c-9cb6-969d36fe6763
Route
TOPICAL
Published
Effective Date 2010-06-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Aloe Vera Leaf Light Mineral Oil Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 1997-10-03

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%

Uses
  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort that accompany these conditions.

  • For the treatment of most superficial skin infections caused by yeast (Candida albicans).

  • Follow a physician's instructions when treating Candida.

Warnings

For external use only.

Directions
Clean the affected area and dry thoroughly.



  • Apply a thin layer of ointment over affected area twice daily (morning and night) or as directed by a physician.
  • Supervise children in use of this product. 

For athlete's foot:  Pay close 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 4 weeks.



For jock itch:  use daily for 2 weeks

  • If condition persists longer, consult a physician.
  • This product is not effective on the scalp or nails.

Do Not Use On
children under 2 years of age unless directed by a physician.

Active Ingredient

Miconazole Nitrate 2%

Other Information

Store at 15oC - 30oC (59oF - 86oF).

If Irritation Occurs
or if there is no improvement within 2 weeks for jock itch, or 4 weeks for athlete's foot or ringworm, discontinue use and consult a physician.
Inactive Ingredients

Aloe Extract, Light Mineral Oil, Softisan 649, White Petrolatum.

Principal Display Panel

NDC 43553-3251-2

ConvaTec

ALOE VESTATM

Antifungal Ointment

TREAT

Miconazole Nitrate 2%

CURES MOST:

Athlete's Foot

Ringworm

Jock Itch

Superficial Yeast Infections

NET WT. 2oz.(56g)

CSX0647A Case Order No. 325102

When Using This Product,

avoid contact with eyes.

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort that accompany these conditions.

  • For the treatment of most superficial skin infections caused by yeast (Candida albicans).

  • Follow a physician's instructions when treating Candida.

Purpose

Antifungal

Warnings

For external use only.

Directions
Clean the affected area and dry thoroughly.



  • Apply a thin layer of ointment over affected area twice daily (morning and night) or as directed by a physician.
  • Supervise children in use of this product. 

For athlete's foot:  Pay close 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 4 weeks.



For jock itch:  use daily for 2 weeks

  • If condition persists longer, consult a physician.
  • This product is not effective on the scalp or nails.

Do Not Use On (Do not use on)
children under 2 years of age unless directed by a physician.

Active Ingredient

Miconazole Nitrate 2%

Other Information

Store at 15oC - 30oC (59oF - 86oF).

If Irritation Occurs (If irritation occurs)
or if there is no improvement within 2 weeks for jock itch, or 4 weeks for athlete's foot or ringworm, discontinue use and consult a physician.
Inactive Ingredients

Aloe Extract, Light Mineral Oil, Softisan 649, White Petrolatum.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 43553-3251-2

ConvaTec

ALOE VESTATM

Antifungal Ointment

TREAT

Miconazole Nitrate 2%

CURES MOST:

Athlete's Foot

Ringworm

Jock Itch

Superficial Yeast Infections

NET WT. 2oz.(56g)

CSX0647A Case Order No. 325102

When Using This Product, (When using this product,)

avoid contact with eyes.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)