SKIN RELIEF CREAM- hydrocortisone lotion 
Spa de Soleil

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Skin Relief Cream

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Inflammatory

Warnings

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.

PL Skin Relief Cream FDA

SKIN RELIEF CREAM 
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-2266
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.45 mg  in 45 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68062-2266-130 mL in 1 TUBE; Type 0: Not a Combination Product11/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01611/19/2023
Labeler - Spa de Soleil (874682867)
Establishment
NameAddressID/FEIBusiness Operations
Spa de Soleil874682867manufacture(68062-2266)

Revised: 11/2023
Document Id: 0a90b77a-4be3-71c5-e063-6294a90a8e41
Set id: 0a90b77a-4be4-71c5-e063-6294a90a8e41
Version: 1
Effective Time: 20231120
 
Spa de Soleil