Leader Antifungal Cream

Leader Antifungal Cream
SPL v2
SPL
SPL Set ID 34f4c733-2eb2-0db0-e063-6394a90a6431
Route
TOPICAL
Published
Effective Date 2025-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Sodium Laureth-4 Phosphate Glyceryl Mono And Dipalmitostearate Ethylparaben Alcohol Carbomer Cetostearyl Alcohol Dimethyl Sulfoxide Edetate Disodium Glycerin Mineral Oil Water Stearic Acid Trolamine Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-12

Description

Miconazole Nitrate 2%

Purpose

Anti-Fungal


Medication Information

Purpose

Anti-Fungal

Description

Miconazole Nitrate 2%

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis)
  • relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
Section 42229-5

Distributed by:

Cardinal Health TM

Dublin, Ohio 43017

www.myleader.com

1-800-200-6313

Essential to Care ™ since 1979

©2024 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO, are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

All Leader Brand Products have a 100% money back guarantee.

Return to place of purchase of not satisfied.

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 51727-6

Inactive ingredients: Alcohol, Carbomer, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, Mineral Oil, Mono and di glycerides, Petrolatum, Polyoxyethylene lauryl ether, purified water, stearic acid, triethanolamine.

Warnings

For external use only. Do not use if the safety-sealed tube is punctured or damaged.

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

When using this product avoid contact with the eyes.

Stop use and ask a doctor • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)

If irritation occurs or if there is no improvement within 2 weeks (for Jock Itch).

Packaging

Directions

Directions: Clean the affected area and dry thoroughly

  • Apply a thin layer of the product over the affected area twice daily, morning and night or as directed by a doctor.
  • Supervise children in the use of this product

For Athletes Foot

  • Use daily for 4 weeks. If condition persists, consult a doctor
  • Pay special Attention to the spaces between the toes
  • Wear well fitting, ventilated shoes
  • Change socks at least once daily

For Ringworm

  • Use daily for 4 weeks. If condition persists, consult a doctor

For Jock Itch

  • Use Daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on scalp and nails

Drug Facts

Active Ingredient

Miconazole Nitrate 2%

Other Information

• Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.


Structured Label Content

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis)
  • relieves itching, scaling, cracking, burning and discomfort associated with these conditions.
Section 42229-5 (42229-5)

Distributed by:

Cardinal Health TM

Dublin, Ohio 43017

www.myleader.com

1-800-200-6313

Essential to Care ™ since 1979

©2024 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO, are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

All Leader Brand Products have a 100% money back guarantee.

Return to place of purchase of not satisfied.

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 51727-6 (51727-6)

Inactive ingredients: Alcohol, Carbomer, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, Mineral Oil, Mono and di glycerides, Petrolatum, Polyoxyethylene lauryl ether, purified water, stearic acid, triethanolamine.

Purpose

Anti-Fungal

Warnings

For external use only. Do not use if the safety-sealed tube is punctured or damaged.

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

When using this product avoid contact with the eyes.

Stop use and ask a doctor • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)

If irritation occurs or if there is no improvement within 2 weeks (for Jock Itch).

Packaging

Directions

Directions: Clean the affected area and dry thoroughly

  • Apply a thin layer of the product over the affected area twice daily, morning and night or as directed by a doctor.
  • Supervise children in the use of this product

For Athletes Foot

  • Use daily for 4 weeks. If condition persists, consult a doctor
  • Pay special Attention to the spaces between the toes
  • Wear well fitting, ventilated shoes
  • Change socks at least once daily

For Ringworm

  • Use daily for 4 weeks. If condition persists, consult a doctor

For Jock Itch

  • Use Daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on scalp and nails

Drug Facts

Active Ingredient (Active ingredient)

Miconazole Nitrate 2%

Other Information

• Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.


Advanced Ingredient Data


Raw Label Data

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