SPL v1
SPL
SPL Set ID 2acb9027-8f20-4b77-9b45-17fe11622c7c
Route
TOPICAL
Published
Effective Date 2025-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Tea Tree Oil Benzoic Acid Cetyl Alcohol Isopropyl Myristate Polysorbate 60 Olive Oil Potassium Hydroxide Propylene Glycol Water Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01

Description

Miconazole nitrate USP, 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole nitrate USP, 2%

Uses

● for the relief of symptoms associated with jack itch ( tinea cruris)

● for effective relief of itching, burning, scaling and discomfort and chafing associated with jock itch

Warnings

For external use only.

Do not use

  • on scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections



When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water.



Stop use and ask a doctor iftoo much irritation occurs or gets worse



Keep out of the reach of children.

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

Directions

Adults and children 12 years and over:

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning andnight)
  • supervise children in the use of this product
  • use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails
  • wash hands after each use
  • in case of clogging, clean with a pin 
  • Children under 12 years: ask a doctor 

Product Label

Active Ingredient

Miconazole nitrate USP, 2%

Other Information
  • do not use if seal on the box is broken or is not visible.
  • store at controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients

Organic tea tree oil, benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, olive oil, potassium hydroxide, propylene glycol, water, stearyl alcohol


Structured Label Content

Uses

● for the relief of symptoms associated with jack itch ( tinea cruris)

● for effective relief of itching, burning, scaling and discomfort and chafing associated with jock itch

Purpose

Antifungal

Warnings

For external use only.

Do not use

  • on scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections



When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water.



Stop use and ask a doctor iftoo much irritation occurs or gets worse



Keep out of the reach of children.

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

Directions

Adults and children 12 years and over:

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning andnight)
  • supervise children in the use of this product
  • use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails
  • wash hands after each use
  • in case of clogging, clean with a pin 
  • Children under 12 years: ask a doctor 

Product Label (Product label)

Active Ingredient

Miconazole nitrate USP, 2%

Other Information (Other information)
  • do not use if seal on the box is broken or is not visible.
  • store at controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

Organic tea tree oil, benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, olive oil, potassium hydroxide, propylene glycol, water, stearyl alcohol


Advanced Ingredient Data


Raw Label Data

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