Active Ingredients...........................................Purpose
Hydrocortisone USP 1%. [in each gram] Antipruritic (Anti-itch)
Terramed Just Think Comfort Hydrocortisone 1% Cream
FDA Label NDC 83004-051
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rida Llc for the product Terramed Just Think Comfort Hydrocortisone 1% Cream (NDC 83004-051). 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...........................................purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
• eczema
• psoriasis
• seborrheic dermatitis
• insect bites
• poison ivy, poison oak, poison sumac
• soaps
• detergents
• cosmetics
• jewelry
Other uses of this product should be only under the advice
and supervision of a doctor.
Warnings
For external use only.
Do not use
• in the eyes
• for the treatment of diaper rash unless directed by a doctor
• for genital or feminine itching if you have a vaginal discharge
Ask a doctor before use if you are
• using any other hydrocortisone product
When using this product
• do not use more than directed unless directed by a doctor
• do not use on large areas of the body
• do not tightly bandage or cover the treated area unless directed by a doctor
Stop use and ask a doctor if
• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• irritation develops
• stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
• adults and children 2 years of age and older: apply a thin layer to the affected area not more than 3 to 4 times daily
• children under 2 years of age: do not use, consult a doctor
Other Information
• store at 20-25°C (68-77°F)
• excursions permitted to 15-30°C (59-86°F)
• protect from excessive heat and freezing
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carbomer, Centella Asiatica Extract, Cetearyl Alcohol, Cetyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate,
Panthenol, Phenoxyethanol, Polysorbate 60, Sodium Hydroxide, Squalane, Stearic Acid, Tocopheryl Acetate, Water.
Product Label
Image Description (Image 1)
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