Active Ingredient
Hydrocortisone 1%
Skin Relief Cream Lotion
FDA Label NDC 68062-2266
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spa De Soleil for the product Skin Relief Cream (NDC 68062-2266). 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, warnings, directions, uses:, inactive ingredients:, warning, 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
Purpose
Anti-Inflammatory
Warnings
- For external use only.
- Avoid contact with the eyes
- If condition worsens or symptoms persist for more than seven days or clear up and occur again within a few days, stope use of this product and do not begin use of any hydrocortisone product until you have consulted a physician.
- Do not use for the treatment of diaper rash. Consult a physician.
- Keep out of reach of children.
Directions
Directions
• Clean the skin thoroughly before applying this product • Cover the entire affected area with a thin layer one to three times daily
Directions(Continued)
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor • If bothersome dryness or peeling occurs, reduce application to once a day or every other day
Uses:
Protects skin from irritation and itching, promoting faster healing and renewal.
Inactive Ingredients:
Water, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Glycerin, Dimethicone, Propylene Glycol, Cetyl Alcohol, Sorbitol, Carthamus Tinctorius (Safflower) Seed Oil, **Squalane, Carbomer, Lactic Acid, Peg-4, Morus Alba Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Kojic Acid, Butylene Glycol, Arctostaphylos Uva-Ursi Leaf Extract, Sodium Hydroxide, Ruscus Aculeatus Root Extract, Ginkgo Biloba Leaf Extract, Diospyros Kaki Fruit Extract, Betula Alba Bark Extract, DMAE, Thioctic Acid, Ubiquinone, *CO Glycerin, Citric Acid, Malic Acid, Gluconic Acid, Ascorbic Acid (Vitamin C), Malus Domestica Fruit Cell Culture Extract, Glycolic Acid, Salicylic Acid, Tartaric Acid, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, Xanthan Gum, Lecithin, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Benzyl Alcohol, Dehydroacetic Acid
Warning
Keep out of reach of children.
* Please review the disclaimer below.
