Restoration Serum Epione: Package Insert and Label Information

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.

​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.

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RESTORATION SERUM EPIONE
hydroquinone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70698-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 2.0 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
MEDIUM-CHAIN TRIGLYCERIDES
ISOPROPYL PALMITATE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
BUTYLENE GLYCOL
AZELAIC ACID
GLYCERIN
CETYL PHOSPHATE
CETOSTEARYL ALCOHOL
DIHEXADECYL PHOSPHATE
CETETH-10 PHOSPHATE
ASCORBIC ACID
ARBUTIN
KOJIC ACID
TROLAMINE
DIMETHICONE
PENTYLENE GLYCOL
PHENYLETHYL RESORCINOL
AVOBENZONE
LEVOMENOL
GLYCYRRHIZA GLABRA
CORN OIL
BUTYLATED HYDROXYTOLUENE
XANTHAN GUM
EDETATE SODIUM
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70698-002-01 30 mL in 1 TUBE None
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 Operations
VEGE-KURL, INC 021072509 manufacture (70698-002)

Revised: 05/2017 Epione Medical Corporation

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