RESTORATION SERUM EPIONE- hydroquinone cream 
Epione Medical Corporation

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.

----------

Restoration Serum

​Active Ingredient:

Hyrdoquinone 2.0%

​Purpose:

Skin Bleaching

​Use:

Skin brightening formula that may help reduce discolorations

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

Stap and ask a doctor if skin irritation becomes severe

​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

​Directions:

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

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.

EPIONE

BEVERLY HILLS

RESTORATION SERUM

1.0 Fl. oz. /  30 ml.

Front

Top back

middle

bottom

RESTORATION SERUM  EPIONE
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70698-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70698-002-0130 mL in 1 TUBE; Type 0: Not a Combination Product05/23/201703/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A05/23/201703/01/2021
Labeler - Epione Medical Corporation (088809509)
Establishment
NameAddressID/FEIBusiness Operations
Vege Labs LLC.117878620manufacture(70698-002)

Revised: 8/2021
 
Epione Medical Corporation