Label: DR MEDECEAN RETURN WHITENING ESSENCE- dimethicone, allantoin liquid

  • 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 September 27, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients: Dimethicone 3.0%, Allantoin 0.5%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Propylheptyl Caprylate, Butylene Glycol, Pentylene Glycol, Sucrose Polystearate, Cetearyl Alcohol, Niacinamide, Beheneth-25, Undecane, Cetearyl Glucoside, BeesWax, Panthenol, Glycerin, Hydrogenated Polyisobutene, Disodium Stearoyl Glutamate, Sucrose, Tridecane, Sucrose Dilaurate, Mannitol, Xanthan Gum, Sodium Polyacrylate, Chlorphenesin, Serine, Arginine, Ammonium Glycyrrhizate, Escin, Citric Acid, PCA, Polysorbate 20, Ruscus Aculeatus Root Extract, Alanine, Sclerotium Gum, Pisum Sativum (pea) Extract, Centella Asiatica Extract, Threonine, Disodium EDTA, Caprylyl Glycol, Hydrolyzed Yeast Protein, Calendula Officinalis Flower Extract, Sodium Citrate, Caffeine, Zinc Gluconate, p-Anisic Acid, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Mourera Fluviatilis Extract

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only

    1. If the Red swellings such as erythema, itchiness, or irritations because of directly sunlight occur, you must stop using immediately and Consult your dermatologist. 2. Do not apply on skin conditions such as wounds. 3. Storage and Handling. a. Keep out of the reach of children. b. Avoid direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses: Dr.MEDECEAN Return Whitening Essence will return your skin to its original tone.

  • Directions

    Directions: After using toner in the morning and evening, apply an appropriate amount evenly throughout the face.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DR MEDECEAN RETURN WHITENING ESSENCE 
    dimethicone, allantoin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70540-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.2 g  in 40 g
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.2 g  in 40 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70540-050-021 in 1 CARTON09/01/2017
    1NDC:70540-050-0140 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2017
    Labeler - INNOGENE CO.,LTD (688201056)
    Registrant - INNOGENE CO.,LTD (688201056)
    Establishment
    NameAddressID/FEIBusiness Operations
    INNOGENE CO.,LTD688201056manufacture(70540-050)