Active Ingredient
Hydrocortisone 1%
Careall Hydrocortisone Cream
FDA Label NDC 51824-197
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 51824-197). 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, otc - purpose, warnings, indications & usage, dosage & administration, inactive ingredient, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti Itch
Warnings
For External use only.
Do not use for the treatment of diaper rash, Consult a doctor.
If you have vaginal discharge, consult a doctor.
When using this product:
avoid contact with eyes
do not use more than directed unless directed by a doctor
do not put into the rectum by using fingers or any mechanical device or applicator
if rectal bleeding occurs, consult a docto promptly
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 and do not begin use of any other hydrocrotisone product unless you have consulted a doctor.
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, consult a physician.
Indications & Usage
For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: ezcema, 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
Dosage & Administration
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 Alchohol, Chlorocresol, Edetate Disodium, Glycerol Monostearate, Mineral Oil, Propylene Glycol, Sodium Metabisulphate, Purified Water, White Petrolatum
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. if swallowed, get medical help or contat a poinson control center right away.
Package Label.Principal Display Panel
Pdp (Pdp)
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