RESTORATION SERUM EPIONE- hydroquinone cream

Restoration Serum by

Drug Labeling and Warnings

Restoration Serum by is a Otc medication manufactured, distributed, or labeled by Epione Medical Corporation, VEGE-KURL, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

​Active Ingredient:

Hyrdoquinone 2.0%

​Purpose:

Skin Bleaching

PURPOSE

​Use: ​

Skin brightening formula that may help reduce discolorations

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stap and ask a doctor if skin irritation becomes severe

WARNINGS

​Warnings:

For External Use only

When using this product:

• avoid unnecessary sun exposure and use a sunscreen
• Some users of this product may experience mild irritation
• Do not use on children under 12 years of age, unless by a doctor
• Keep away from eyes, lips and mouth
• Avoid contact with hair and dyed fabrics, including carpets and clothing which may be bleached with this product
• Lightening effect may not be noticeable when used on very dark skin
• This product may darken over time, which is normal and does not affect the product performance

DOSAGE & ADMINISTRATION

​Directions:

Cleanse the skin thoroughly before use. Cover the affected area with thin layer morning and night. Use sunscreen daily.

INACTIVE INGREDIENT

Water (Aqua), Propylene Glycol, Caprylic/Capric Triglyceride, Isopropyl Palmitate, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Azelaic Acid, Glycerin, Cetyl Phosphate, Cetearyl Alcohol, Dicetyl Phosphate, Ceteth-10 Phosphate, Rumex Occidentalis Extract, Ascorbic Acid, Arbutin, Kojic Acid, Triethanolamine, Dimethicone, Pentylene Glycol, Phenylethyl Resorcinol, Butyl Methoxydibenzoylmethane, Bisablolol, Glycyrrhiza Glabra (Licorice) Root Extract, Zea Mays (Corn) Oil, BHT, Xanthan Gum, Tetrasodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Phenoxyethanol, Fragrance.

PRINCIPAL DISPLAY PANEL

EPIONE

BEVERLY HILLS

RESTORATION SERUM

1.0 Fl. oz. /  30 ml.

INGREDIENTS AND APPEARANCE

RESTORATION SERUM  EPIONE
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70698-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
AZELAIC ACID (UNII: F2VW3D43YT)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL PHOSPHATE (UNII: VT07D6X67O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ARBUTIN (UNII: C5INA23HXF)
KOJIC ACID (UNII: 6K23F1TT52)
TROLAMINE (UNII: 9O3K93S3TK)
DIMETHICONE (UNII: 92RU3N3Y1O)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
AVOBENZONE (UNII: G63QQF2NOX)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CORN OIL (UNII: 8470G57WFM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE SODIUM (UNII: MP1J8420LU)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70698-002-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	05/23/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	05/23/2017

Labeler - Epione Medical Corporation (088809509)

Registrant - VEGE-KURL, INC (021072509)

Establishment
Name	Address	ID/FEI	Business Operations
VEGE-KURL, INC		021072509	manufacture(70698-002)