Careall Clotrimazole Cream
FDA Label NDC 51824-063

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 Clotrimazole (NDC 51824-063). 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

Clotrimazole 1%

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 immediately.

Uses

  • Cures most athlete's foot, jock itch and ringworm.
  • Relieves itching, burning, cracking, scaling, and discomfort which accomany 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
  • there is no improvement in 4 weeks (for athlete's foot for ringworm) or 2 weeks (for jock itch)

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • 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 atlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Inactive Ingredients

Cetomacrogol 1000, Cetostearyl Alcohol, Liquid Paraffin, Methylparaben, Propylene Glycol, Propylparaben, Water, White Soft Paraffin

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