Label: MEDI HYDRO DP- glycerin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 24, 2019

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  • INDICATIONS & USAGE

    Apply enough amount of cream on clean face, gently massage until perfectly absorbed.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    for external use only

  • WARNINGS

    Discontinue use of the product if any of the following symptoms occurred. Consult a dermatologist if the symptoms got worse.
    a) If redness, Swelling, Itchiness, Irritation occurred during using.
    b) If the above symptoms started to occur when exposed to direct sunlight.
    Do not use on skins with wounds, eczema or dermatitis.

    Storage instructions
    a) Always close the lid after finish using.
    b) Store in a safe place away and out of reach of children.
    c) Store in a place with not too high or low temperature, keep awayfrom direct sunlight exposure.

  • PURPOSE

    High moisturization-freshening cream that stays on the skin without sticky feeling

  • INACTIVE INGREDIENT

    water, butylene glycol, niacinamide, etc.

  • ACTIVE INGREDIENT

    glycerin

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    MEDI HYDRO DP 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70694-0011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70694-0011-150 g in 1 BOTTLE; Type 0: Not a Combination Product01/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34701/24/2019
    Labeler - Inc MBG (688436167)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inc MBG688436167manufacture(70694-0011)
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