Label: DR.ALTHEA HYDRATION BOOSTING SERUM- 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 August 12, 2016

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  • ACTIVE INGREDIENT

    DIMETHICONE

  • INACTIVE INGREDIENT

    SQUALANE,HYDROLYZED HYALURONIC ACID,ALGAE EXTRACT,WATER,BUTYLENE GLYCOL,ETC

  • PURPOSE

    Helps Hydrate skin

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    After using a skin toner, apply this product to skin and spread it over skin evenly once or twice every morning and night.

  • WARNINGS

    1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
    1) Occurrence of red spots, swelling, itchiness, and other skin irritation
    2) If the symptoms above occur after the application area is exposed to direct sunlight
    2. Do not use on open wounds, eczema, and other skin irritations
    3. Precaution for Storage and Handling
    1) Close the lid after use
    2) Keep out of reach of infants and children
    3) Do not to store in a place with high/low temperature and exposed to direct sunlight

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DR.ALTHEA HYDRATION BOOSTING SERUM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70905-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70905-0003-150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/11/2016
    Labeler - Dr. Althea (689694436)
    Registrant - Dr. Althea (689694436)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Althea689694436manufacture(70905-0003)
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