Label: MEDI HYDRO DP MIST- glycerin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 24, 2019

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  • INDICATIONS & USAGE

    spray proper amount to the skin

  • 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

    for skin protectant

  • INACTIVE INGREDIENT

    water, butylene glycol, xanthan gum, sodium carbomer, etc.

  • ACTIVE INGREDIENT

    glycerin

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    MEDI HYDRO DP MIST 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70694-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70694-0005-1100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/24/2019
    Labeler - Inc MBG (688436167)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inc MBG688436167manufacture(70694-0005)