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Cell Renew Bio Eye Special Set

Dosage form: cream
Ingredients: Dimethicone 0.75g in 30mL
Labeler: The Saem International Co., Ltd.
NDC Code: 70341-040

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

Active Ingredients: Dimethicone 2.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Butylene Glycol, Squalane, Pentaerythrityl Tetraethylhexanoate, Diisostearyl Malate, Polyglyceryl-3 Methylglucose Distearate, Glyceryl Stearate, Niacinamide, Limnanthes Alba (Meadowfoam) Seed Oil, Butylene Glycol Dicaprylate/Dicaprate, Cetyl Ethylhexanoate, Pentylene Glycol, Cyclopentasiloxane, Cetearyl Alcohol, Behenyl Alcohol, Butyrospermum Parkii (Shea) Butter, Acetyl Glucosamine, Cyclohexasiloxane, Copernicia Cerifera (Carnauba) Wax, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Polyacrylate-13, Tocopheryl Acetate, Fragrance(Parfum), Polyisobutene, Xanthan Gum, Adenosine, Eryngium Maritimum Callus Culture Filtrate, Disodium EDTA, Maltodextrin, Hydrolyzed Avocado Protein, Polysorbate 20, Water, Sodium Cocoyl Alaninate, Sodium Hyaluronate, Palmitoyl Isoleucine, Milk Lipids, Theanine, Melia Azadirachta Flower Extract, Glutathione, Theobroma Cacao (Cocoa) Extract, Melia Azadirachta Leaf Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Basilicum (Basil) Flower/Leaf Extract, Lawsonia Inermis (Henna) Flower/Fruit/Leaf Extract, Ocimum Sanctum Leaf Extract, Corallina Officinalis Extract, Ceramide 3, Aqua, Stearic Acid, Cholesterol, Caprylic/Capric Triglyceride, Phytosphingosine, Lactic Acid, Oleic Acid, Hydrogenated Lecithin, Caprylhydroxamic Acid

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warning: 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. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of Children: Keep out of reach of babies and children

INDICATIONS & USAGE

Indication & Usage: Take an adequate amount and apply evenly around eyes for better absorption.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CELL RENEW BIO EYE SPECIAL SET 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-040
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (DIMETHICONE) Dimethicone0.75 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:70341-040-0130 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/2015
Labeler - The Saem International Co., Ltd. (689402402)
Registrant - The Saem International Co., Ltd. (689402402)
Establishment
NameAddressID/FEIOperations
The Saem International Co., Ltd.689402402manufacture(70341-040)

Revised: 12/2015
 
The Saem International Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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