antifungal cream

antifungal cream
SPL v2
SPL
SPL Set ID 8b1f3301-c1cb-4263-8302-20d5df619019
Route
topical
Published
Effective Date 2012-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
miconazole (20 mg)
Inactive Ingredients
butylated hydroxytoluene cetostearyl alcohol glycerin glyceryl monostearate methylparaben magnesium aluminum silicate petrolatum propylparaben polyoxyl 40 stearate water

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-09-05

Purpose

Antifungal

Description

Miconazole Nitrate 2%


Medication Information

Warnings

​For external use only.

​PRECAUTIONS: ​ For external use only. Not intended for ingestion. Avoid contact with eyes.

Uses

Treats jock itch, ringworm, and athlete's foot.

​INDICATIONS:​ Proven clinically effective in the treatment athlete's foot, jock itch and ringworm. Treats superficial skin infections caused by yeast. For effective relief of redness, irritation, itching, and burning.

Purpose

Antifungal

Directions

​Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician
  • supervise children in the use of this product

​Athlete's Foot

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

​Athlete's Foot and Ringworm

  • use daily for 4 weeks

​Jock Itch

  • use daily for 2 weeks

This product is not effective on scalp or nails.

Inactive Ingredients

BHT, Cetostearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Magnesium Aluminum Silicate, Petrolatum, Propylparaben, Polyoxyl 40 Stearate, Purified Water.

Description

Miconazole Nitrate 2%

Storage

Store at room temperature 15-30C (59-86F).

Questions

Manufactured for PSS World Medical, Inc.

4345 Southpoint Blvd., Jacksonville, FL 32216

Comments or Questions? 800-777-4908

Made in China

Do Not Use

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

Package Label

NDC 68345-817-25

6391 Each

6391 Box

Active Ingredient

Miconazole Nitrate 2%

Stop Use and Ask A Doctor If

Stop use and ask a doctor if

  • irritation develops
  • there is no improvement within 4 weeks for athlete's foot or ringworm
  • or within 2 weeks for jock itch
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.


Structured Label Content

Warnings

​For external use only.

​PRECAUTIONS: ​ For external use only. Not intended for ingestion. Avoid contact with eyes.

Uses

Treats jock itch, ringworm, and athlete's foot.

​INDICATIONS:​ Proven clinically effective in the treatment athlete's foot, jock itch and ringworm. Treats superficial skin infections caused by yeast. For effective relief of redness, irritation, itching, and burning.

Purpose

Antifungal

Directions

​Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician
  • supervise children in the use of this product

​Athlete's Foot

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

​Athlete's Foot and Ringworm

  • use daily for 4 weeks

​Jock Itch

  • use daily for 2 weeks

This product is not effective on scalp or nails.

Inactive Ingredients

BHT, Cetostearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Magnesium Aluminum Silicate, Petrolatum, Propylparaben, Polyoxyl 40 Stearate, Purified Water.

Storage

Store at room temperature 15-30C (59-86F).

Questions

Manufactured for PSS World Medical, Inc.

4345 Southpoint Blvd., Jacksonville, FL 32216

Comments or Questions? 800-777-4908

Made in China

Do Not Use (Do not use)

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

Package Label

NDC 68345-817-25

6391 Each

6391 Box

Active Ingredient

Miconazole Nitrate 2%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if

  • irritation develops
  • there is no improvement within 4 weeks for athlete's foot or ringworm
  • or within 2 weeks for jock itch
Keep Out of Reach of Children (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.


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