169 Remedy Clinical Treat Antifungal Powder

169 Remedy Clinical Treat Antifungal Powder
SPL v7
SPL
SPL Set ID 021b4a31-d7f6-4921-b4b1-cbe832eecd93
Route
TOPICAL
Published
Effective Date 2024-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Aphanizomenon Flos-aquae Green Tea Leaf Caprylic/capric/linoleic Triglyceride 7-dehydrocholesterol Glycyrrhizinate Dipotassium Ethylene Brassylate Clove Glycerin Soy Protein Isopropyl Myristate Methyl Dihydrojasmonate (synthetic) Egg Phospholipids Hydrated Silica Sodium Benzoate .alpha.-tocopherol Acetate Vanilla Water Yeast Corn Oil Starch, Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-11-19

Description

Miconazole nitrate 2.0% w/w

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole nitrate 2.0% w/w

Uses
  • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
Warnings

For external use only

Directions
  • Clean the affected area and dry thoroughly
  • Apply a thin layer of powder over affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete's foot, pay special attention between spaces in 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 doctor
  • This product is not effective on the scalp or nails.
Do Not Use
  • on children under 2 years of age unless directed by a doctor
  • on scalp or nails
Package Label

Active Ingredient

Miconazole nitrate 2.0% w/w

Other Information
  • protect from freezing. Avoid excessive heat.
  • do not use if package is damaged
  • keep dry
Inactive Ingredients

Aphanizomenon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglycerides, 7-Dehydrocholesterol, Dipotassium Glycyrrhizate, Ethylene Brassylate, Eugenia Caryophyllus (Clove) Flower Extract, Fragrance, Glycerin, Hydrolyzed Soy Protein, Phospholipids, Silica, Sodium Benzoate, Tocopheryl Acetate, Water, Yeast Ferment Extract, Zea Mays (Corn) Oil, Zea Mays (Corn) Starch

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor
  • if irritation occurs
  • there is no improvement within 4 weeks when used for the treatment of athlete's foot or ringworm
  • there is no improvement within 2 weeks when used for the treatment of jock itch
Keep Out of Reach of Children

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


Structured Label Content

Uses
  • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
Purpose

Antifungal

Warnings

For external use only

Directions
  • Clean the affected area and dry thoroughly
  • Apply a thin layer of powder over affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete's foot, pay special attention between spaces in 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 doctor
  • This product is not effective on the scalp or nails.
Do Not Use (Do not use)
  • on children under 2 years of age unless directed by a doctor
  • on scalp or nails
Package Label

Active Ingredient (Active ingredient)

Miconazole nitrate 2.0% w/w

Other Information
  • protect from freezing. Avoid excessive heat.
  • do not use if package is damaged
  • keep dry
Inactive Ingredients (Inactive ingredients)

Aphanizomenon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglycerides, 7-Dehydrocholesterol, Dipotassium Glycyrrhizate, Ethylene Brassylate, Eugenia Caryophyllus (Clove) Flower Extract, Fragrance, Glycerin, Hydrolyzed Soy Protein, Phospholipids, Silica, Sodium Benzoate, Tocopheryl Acetate, Water, Yeast Ferment Extract, Zea Mays (Corn) Oil, Zea Mays (Corn) Starch

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if irritation occurs
  • there is no improvement within 4 weeks when used for the treatment of athlete's foot or ringworm
  • there is no improvement within 2 weeks when used for the treatment of 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.


Advanced Ingredient Data


Raw Label Data

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