OROCHE DERMA REJUVENATOR- witch hazel cream 
OROCHE

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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ACTIVE INGREDIENT

Active Ingredient: Hamamelis virginiana(Witch Hazel) Extract 0.01%

INACTIVE INGREDIENT

Inactive Ingredients: D.I WATER, Galactomyces Ferment Filtrate, Butylene Glycol, Sodium Hyaluronate, Alcohol Denat., Glycerin, Niacinamide, Panthenol, Human Oligopeptide-1, PEG-60 Hydrogenated Castor Oil, rhiza Glabra (Licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Schizandra Chinensis Fruit Extract, Coptis Chinensis Root Extract, Camellia Sinensis Leaf Extract, Asiaticoside, Propolis Wax, 1,2-Hexanediol, Chlorphenesin, Arginine, Carbomer, Sodium Polyacrylate, Adenosine, Fragrance

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. Cautions on storage 1)Keep the cap seal. 2) Keep out of reach of babies and children 3)Do not leave it on high, low temperature or exposed on sunlight.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children

INDICATIONS & USAGE

Indications & Usage: Shake it up and down to mix the highly concentrated powder and activated liquid after turning the container upside down and twist it to the right - bust the inner membrance. Press the pump and take appropriate amount, then spread it onto the skin. After that pad the skin lightly for the product to be absorbed well. It is highly recommended to keep this mixed highly concentrated powder and ample in the refrigerator and to be consumed within 30 days.

DOSAGE & ADMINISTRATION

Dosage & Administration: Use the eyedropper to pump 1-2times.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

OROCHE DERMA REJUVENATOR 
witch hazel cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69712-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) Witch Hazel0.001 mg  in 12 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69712-010-0112 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2015
Labeler - OROCHE (689512761)
Registrant - OROCHE (689512761)
Establishment
NameAddressID/FEIBusiness Operations
OROCHE689512761manufacture(69712-010)

Revised: 4/2015
Document Id: 3bde65db-e204-4deb-917e-c78c2d4237ca
Set id: 8ce7b1e4-7ca1-4af5-8c5c-79e565d459d9
Version: 2
Effective Time: 20150407
 
OROCHE