Miconazole Nitrate Antifungal Cream

Miconazole Nitrate Antifungal Cream
SPL v2
SPL
SPL Set ID 1ff4dcb5-d4ac-4e4b-a1ae-993f28939942
Route
TOPICAL
Published
Effective Date 2012-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Benzoic Acid Butylated Hydroxyanisole Mineral Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-03-20

Description

Miconazole nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole nitrate 2%

Uses
  • treats most athlete’s foot, jock itch and ringworm
  • relieves itching, scaling, burning, irritation and discomfort
Warnings

For external use only

Directions
  • clean 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
  • this product does not work on the scalp or nails

For athlete’s foot

  • pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once every day

    For athlete’s foot and ringworm

  • use every day for 4 weeks

    For jock itch

  • use every day for 2 weeks. If condition lasts longer, contact a doctor.
Active Ingredient

Miconazole nitrate 2%

Other Information

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

IMPORTANT: The opening of this product is covered by a metal tamper-evident seal. If this seal has been punctured or is not visible, do not use and return product to place of purchase.

TO OPEN: To puncture the seal, reverse the cap and place the puncture-top onto the tube. Push firmly until seal is open. To close, screw the cap back onto the tube.

Inactive Ingredients

Benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

When Using This Product
  • do not get into the eyes
Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot or ringworm) or within 2 weeks (for jock itch)

Do not use on children under 2 years, unless directed by a doctor.

Keep Out of Reach of Children

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

Package Label.principal Display Panel

NDC 54868-2471-0



Compare to the active ingredient in Micatin® Antifungal Cream*

Actavis

Antifungal Cream

Miconazole Nitrate 2%

Relieves Burning, Cures Most Athlete’s Foot, Jock Itch, Ringworm

Net wt. 14 g  tube cream

07350200D1 VC106266











Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma      74146


Structured Label Content

Uses (USES)
  • treats most athlete’s foot, jock itch and ringworm
  • relieves itching, scaling, burning, irritation and discomfort
Purpose (PURPOSE)

Antifungal

Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)
  • clean 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
  • this product does not work on the scalp or nails

For athlete’s foot

  • pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once every day

    For athlete’s foot and ringworm

  • use every day for 4 weeks

    For jock itch

  • use every day for 2 weeks. If condition lasts longer, contact a doctor.
Active Ingredient (ACTIVE INGREDIENT)

Miconazole nitrate 2%

Other Information (OTHER INFORMATION)

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

IMPORTANT: The opening of this product is covered by a metal tamper-evident seal. If this seal has been punctured or is not visible, do not use and return product to place of purchase.

TO OPEN: To puncture the seal, reverse the cap and place the puncture-top onto the tube. Push firmly until seal is open. To close, screw the cap back onto the tube.

Inactive Ingredients (INACTIVE INGREDIENTS)

Benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

When Using This Product (WHEN USING THIS PRODUCT)
  • do not get into the eyes
Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot or ringworm) or within 2 weeks (for jock itch)

Do not use on children under 2 years, unless directed by a doctor.

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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 54868-2471-0



Compare to the active ingredient in Micatin® Antifungal Cream*

Actavis

Antifungal Cream

Miconazole Nitrate 2%

Relieves Burning, Cures Most Athlete’s Foot, Jock Itch, Ringworm

Net wt. 14 g  tube cream

07350200D1 VC106266











Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma      74146


Advanced Ingredient Data


Raw Label Data

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