Active Ingredients (Each Gram Contains)
Hydrocortisone 1%
Procure Hydrocortisone Cream Plus Cream
FDA Label NDC 29784-142
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rooftop Consumer Health, Inc. for the product Procure Hydrocortisone Cream Plus (NDC 29784-142). 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 ingredients (each gram contains), purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-itch
Uses
• temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema • psoriasis • poison ivy, oak, sumac • insect bites • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • other uses of this product should only be 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.
When Using This Product
• avoid contact with eyes
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.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
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: ask a doctor
Other Information
Store at controlled room temperature 68-77°F (20-25°C).
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Butylene Glycol, Calendula Officinalis Flower Extract, Caprylyl Glycol, Ceratonia Siliqua (Carob) Gum, Ceteareth-20, Cetearyl Alcohol, Chondrus Crispus (Carrageenan), Cocos Nucifera (Coconut) Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE, Hexylene Glycol, Isopropyl Myristate, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol
Questions Or Comments?
Call 1-800-526-3668
Package Labeling:
Label (Label)
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