Label: OROCHE DERMA REJUVENATOR- witch hazel cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69712-010-01 - Packager: OROCHE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 7, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
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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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OROCHE DERMA REJUVENATOR
witch hazel creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69712-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) Witch Hazel 0.001 mg in 12 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69712-010-01 12 mL in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/01/2015 Labeler - OROCHE (689512761) Registrant - OROCHE (689512761) Establishment Name Address ID/FEI Business Operations OROCHE 689512761 manufacture(69712-010)
