Terramed Just Think Comfort Jock Itch Antifungal Treatment Liquid
FDA Label NDC 83004-020

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rida Llc for the product Terramed Just Think Comfort Jock Itch Antifungal Treatment (NDC 83004-020). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Miconazole nitrate USP, 2%

Purpose

Antifungal

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 

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

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