Label: PHARMASKINCARE BRIGHTENING DERMARELIEF CREAM- hydrocortisone lotion
- NDC Code(s): 68062-9103-1
- Packager: Spa de Soleil
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 11, 2017
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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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
- Uses:
-
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PHARMASKINCARE BRIGHTENING DERMARELIEF CREAM
hydrocortisone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68062-9103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 0.025 mg in 2.5 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) SAFFLOWER OIL (UNII: 65UEH262IS) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68062-9103-1 50 mL in 1 JAR; Type 0: Not a Combination Product 10/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/10/2017 Labeler - Spa de Soleil (874682867) Establishment Name Address ID/FEI Business Operations Spa de Soleil 874682867 manufacture(68062-9103)
