ULTRA SOOTHING FORMULA (DIMETHICONE) CREAM [DERMAFIRM INC.]

ULTRA SOOTHING FORMULA (DIMETHICONE) CREAM [DERMAFIRM INC.]
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NDC 71638-0009-1
Set ID 68d656e4-9777-4fe2-e053-2a91aa0a9fab
Category HUMAN OTC DRUG LABEL
Packager Dermafirm INC.
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Dimethicone

  • INACTIVE INGREDIENT

    Water, Beeswax, etc

  • PURPOSE

    Skin Protectant - Soothing, Moisturizing

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    After using toner, apply this lotion on your face.
    Gently spread and tap.

  • 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 external use only


  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ULTRA SOOTHING FORMULA 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71638-0009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71638-0009-1200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/02/2018
    Labeler - Dermafirm INC. (690171603)
    Registrant - Dermafirm INC. (690171603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermafirm INC.690171603label(71638-0009) , pack(71638-0009) , manufacture(71638-0009)

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