Otc - Active Ingredient
Active Ingredient.........Purpose
Hydrocortisone 1% .....Anti-itch
Truelipids 1% Hydrocortisone Barrier Cream
FDA Label NDC 61387-252
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Claridei Laboratories for the product Truelipids 1% Hydrocortisone Barrier Cream (NDC 61387-252). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- psoriasis
- poison ivy, oak, sumac
- insect bites
- detergents
- soaps
- cosmetics
- jewelry
- seborrheic dermatitis
- temporarily relieves external anal and genital itching
- other uses of this product should only be under the advice and supervision of a doctor
Otc - 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.
Indications & Usage
Stop use and ask a doctor if
- condition worsens
- rectal bleeding occurs
- symptoms persist more than 7 days or clear up and occur again within a few days. do not begin use of any other hydrocortisone product unless you have asked a doctor
Warnings
Warnings
For external use only
Do not use
- in the genital area if you have a vaginal discharge. consult a doctor
- for the treatment of diaper rash. consult a doctor
when using this product
avoid contact with eyes
do not use more than directed unless told to do so by a doctor
do not put directly into rectim by using fingers or any mechanical device or applicator
Dosage & Administration
Directions
- for itching of skin irritation, inflammation and rashes:
- adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
- children under 2 years of age: ask a doctor
- for external anal and genital itching adult:
- when practical clean the affected area with mild soap and water and rinse thoroughly
- gently dry by patting or blotting with toilet tissueor a soft cloth before applying
Inactive Ingredient
Inactive ingredients
Water, Caprylic/capric Triglyceride, Petrolatum, Neopentyl Glycol Diheptanoate, Glyceryl Stearate, Polyglyceryl-2 Stearate, Isostearyl Isostearate, Cetyl Allcohol, Propanediol (from Corn) , Glycerin, Stearyl Alcohol, Euphorbia Cerifera (Candelilla Wax), C10-30 Cholesterol/Lanosterol Esters, Potassium Stearate, Glycyrrhetinic Acid(from Licorice root), Glyceryl Distearate, Stearic Acid, Caprylyl Glycol, Xanthan Gum, Niacinamide, 1,2-Hexanediol, Phytospingosine, Disodium EDTA, Ceramide NP, Tocopherol
Other Safety Information
Other information
store at 20°-25°C (68°-77°F)
Package Label.Principal Display Panel
CLMD
Sensitive Skin Care
True Lipids
1% Hydrocortisone Barrier Cream
Net Wt 1.7 fl oz (50g)
Hydrocortisone (Clmd Tl Hydrocortisone 50g Carton Path)
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