Label: BABY ESSENCE- glycerin essence solution

  • 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 July 17, 2017

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

  • ACTIVE INGREDIENT

    Glycerin (9.5%) - Skin Protectant

  • INACTIVE INGREDIENT

    Water, Lemon Balm Extract, Olive Oil, Angelica Gigas NAKAI Extract, Ethanol, N-acetyl Glucosamine, Ascorbic Acid

  • PURPOSE

    Skin Protectant

  • WARNINGS

    When using this product
     avoid contact with eyes
    Stop use and ask a doctor if
     you have allergy or skin disease
     rash or irritation develops and lasts
     red spots, swelling, itching, irritation and other abnormalities develops

  • KEEP OUT OF REACH OF CHILDREN

     if swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

     Clean skin thoroughly before using
     Squeeze 1 or 2 pumps onto palm
     Apply lightly to baby’s face and body
     Frequency of usage should accord to skin condition

  • DOSAGE & ADMINISTRATION

     Clean skin thoroughly before using
     Squeeze 1 or 2 pumps onto palm
     Apply lightly to baby’s face and body
     Frequency of usage should accord to skin condition

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BABY ESSENCE 
    glycerin essence solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71538-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin9.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Tocopherol (UNII: R0ZB2556P8)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71538-005-01100 mL in 1 PACKAGE; Type 0: Not a Combination Product07/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/17/2017
    Labeler - NANONATURE (689851291)
    Registrant - NANONATURE (689851291)
    Establishment
    NameAddressID/FEIBusiness Operations
    NANONATURE689851291manufacture(71538-005)