PHARMASKINCARE MULTI-GLY SKIN RELIEF CREAM- hydrocortisone lotion 
Spa de Soleil

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.

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Pharmaskincare Multi-Gly Skin Relief Cream

Active Ingredient

Hydrocortisone 1%

Purpose

External Analgesic

Warnings

Directions

Adults and children two years of age and older: Apply to affected area not more than three or four times daily. Children under two years of age: Do not use; consult a physician.

Uses:

For the temporary relief of itching associated with minor skin irritations and rashes. Other uses of this product should be only under the advice and supervision of a physician.

Inactive Ingredients:

Water, Glycerin, Cetyl Alcohol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Stearic Acid, PEG-100 Stearate, Glyceryl Stearate, Glycolic Acid, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Dimethicone, Ethylhexyl Palmitate, Polyglyceryl-3 Beeswax, Polyglyceryl-6 Distearate, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Hydroxyethylcellulose, Magnesium Aluminum Silicate, Thioctic Acid, Ubiquinone, *CO Glycerin, Malus Domestica Fruit Cell Culture Extract, *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, Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Sodium Hydroxide, Benzyl Alcohol, Fragrance, Dehydroacetic Acid

Warning

Keep out of reach of children.

Pharmaskincare MultiGlySkinRelief.jpg

Pharmaskincare MultiGlySkinRelief.jpg

PHARMASKINCARE MULTI-GLY SKIN RELIEF CREAM 
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-9106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.025 mg  in 2.5 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68062-9106-150 mL in 1 JAR; Type 0: Not a Combination Product10/10/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/10/2017
Labeler - Spa de Soleil (874682867)
Establishment
NameAddressID/FEIBusiness Operations
Spa de Soleil874682867manufacture(68062-9106)

Revised: 10/2017
Document Id: 5b4e8ef1-2985-cf1c-e053-2a91aa0aa771
Set id: 5b4e8ef1-2984-cf1c-e053-2a91aa0aa771
Version: 1
Effective Time: 20171011
 
Spa de Soleil