Careall Hydrocortisone Cream
FDA Label NDC 51824-050

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 Hydrocortisone (NDC 51824-050). 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 ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

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

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

eczema, psoriasis, poison ivy, poison oak, poison sumac, insect bites, detergents, jewelry, seborrheic dermatitis, soaps, external itching and anal itching.

Other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use:

For the treatment of diaper rash.  Ask a doctor

For external genital itching if you have a vaginal discharge.  Ask a doctor

When using this product:

Avoid contact with the eyes

Do not begin use of any other Hydrocortisone product unless you have asked a doctor

For external anal itching do not exceed the recommended daily dosage unless directed by a doctor.  In case of bleeding, consult a doctor promptly.

Do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if:

Condition worsens

Symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Adults and children 2 years of age and older:

  • apply to affected area not more than 3 to 4 times daily.

    • Children under 2 years of age:

    • do not use.  Ask a doctor.

      • For external anal itching:

      • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.  Gently dry by patting or blotting with toliet tissue or a soft cloth before application of this product.
      • children under 12 years of age with external anal itching: ask a doctor.

Inactive Ingredient

Cetamacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Metabisulphite, White Soft Paraffin

* Please review the disclaimer below.