Careall Miconazole Nitrate Cream
FDA Label NDC 51824-078

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall Miconazole Nitrate (NDC 51824-078). 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, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

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 (1-800-222-1222).

Uses

  • Proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm.
  • Fore effective relief of itching, scaling, burning and discomfort that can accompany these conditions.

Warnings

For external use only.

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

When using this product avoide contact with eyes

Stop use and ask doctor if

  • irritation occurs
  • condition persists
  • there is no improvement of athlete's foot or ringworm within 4 weeks and jock itch within 2 weeks

Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product 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 the 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
  • not effective on the scalp or nails

Inactive Ingredients

Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Purified Water, White Petrolatum

* Please review the disclaimer below.