Label: QUERENCIA CREAMFOR CHILDREN- dimethicone cream

  • 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 January 4, 2019

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

  • ACTIVE INGREDIENT

    dimethicone

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, ButyrospermumParkii (Shea Butter), Glycerin, SparassisCrispa Extract, Betaine, Theobroma Cacao (Cocoa) Seed Butter, Beeswax, Bentonite, Hydrogenated Polydecene, Olea Europaea (Olive) Fruit Oil, Caprylic/Capric Triglyceride, Squalane, Portulaca Oleracea Extract, Hydrogenated Polyisobutene, Cetearyl Alcohol, Stearyl alcohol, Glyceryl Stearate SE, Arginine, Potassium Cetyl Phosphate, Stearic Acid, Caprylyl Glycol, Hydrogenated Palm Glycerides, Polyisobutene, Cyclohexasiloxane, Cyclopentasiloxane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Dimethicone/Vinyl DimethiconeCrosspolymer, Polyacrylate-13, 1,2-Hexanediol, Tromethamine, Polysorbate 20, Disodium EDTA

  • PURPOSE

    for sensitive and dry skin

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Apply to the skin and gently rub it to absorb it

  • WARNINGS

    1. Do not use in the following cases(Eczema and scalp wounds)

    2.Side Effects

    1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor

    3.General Precautions

    1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately

    2)This product is for exeternal use only. Do not use for internal use

    4.Storage and handling precautions

    1)If possible, avoid direct sunlight and store in cool and area of low humidity

    2)In order to maintain the quality of the product and avoid misuse

    3)Avoid placing the product near fire and store out in reach of children

  • DOSAGE & ADMINISTRATION

    for topical use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    QUERENCIA CREAMFOR CHILDREN 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70488-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70488-0010-150 mL in 1 JAR; Type 0: Not a Combination Product01/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/04/2019
    Labeler - MUSEE Cosmetic Co.,Ltd. (689605445)
    Registrant - MUSEE Cosmetic Co.,Ltd. (689605445)
    Establishment
    NameAddressID/FEIBusiness Operations
    MUSEE Cosmetic Co.,Ltd.689605445manufacture(70488-0010)