Miconazole Nitrate 2%

Miconazole Nitrate 2%
SPL v2
SPL
SPL Set ID 1a26534d-eeb8-8d17-e063-6294a90a70c7
Route
TOPICAL
Published
Effective Date 2024-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Allantoin Chloroxylenol Imidurea Microcrystalline Cellulose Tricalcium Phosphate Starch, Corn

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-05

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • for the treatment of most superficial skin infections caused by yeast (candida albicans)
  • relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

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 to spaces between toes; wear well - fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athletes 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 by a doctor
  • avoid contact with the eyes
  • for athlete's foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor
  • for jock itch - if irritation occurs, or if there is no improvement within 2 weeks, dicontinue use and consult a doctor
Active Ingredient

Miconazole Nitrate 2.0%

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

allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalcium phosphate, corn starch

Principal Display Panel 85 G Bottle Label


Structured Label Content

Uses
  • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • for the treatment of most superficial skin infections caused by yeast (candida albicans)
  • relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

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 to spaces between toes; wear well - fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athletes 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 by a doctor
  • avoid contact with the eyes
  • for athlete's foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor
  • for jock itch - if irritation occurs, or if there is no improvement within 2 weeks, dicontinue use and consult a doctor
Active Ingredient (Active ingredient)

Miconazole Nitrate 2.0%

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

allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalcium phosphate, corn starch

Principal Display Panel 85 G Bottle Label (PRINCIPAL DISPLAY PANEL - 85 g Bottle Label)


Advanced Ingredient Data


Raw Label Data

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