Careall Hydrocortisone Cream
FDA Label NDC 51824-098

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 51824-098). 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 right away

Uses

  • For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:   eczema, psoriasis, poison ivy, oak & sumac, insect bites, detergents, jewelry, seborrheic dermatitis, and soap
  • 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.  Consult a doctor

When using this product:

Avoid contact with the eyes

Do not begin use of any other hydrocortisone product unless you have consulted a doctor

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.

Inactive Ingredient

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

* Please review the disclaimer below.