PHARMASKINCARE MULTI-GLY SKIN RELIEF CREAM- hydrocortisone lotion

Pharmaskincare Multi-Gly Skin Relief Cream by

Drug Labeling and Warnings

Pharmaskincare Multi-Gly Skin Relief Cream by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1%

Purpose

External Analgesic

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

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.

PRINCIPAL DISPLAY PANEL

Pharmaskincare MultiGlySkinRelief.jpg

INGREDIENTS AND APPEARANCE

PHARMASKINCARE MULTI-GLY SKIN RELIEF CREAM 
hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-9106
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)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-9106-1	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(68062-9106)