Label: SANDAWHA SOFT BABY WASH- glycerin cream

  • Category: HUMAN OTC DRUG LABEL

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 February 23, 2019

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  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    Camellia Japonica Flower Extract
    Disodium Cocoamphodiacetate
    Lauryl Glucoside
    Sodium Lauroyl Glutamate
    Glycerin
    Pentylene Glycol
    Citric Acid
    Sorbitan Caprylate
    Panthenol
    Propanediol
    Trehalose
    Water(Aqua)
    Centella Asiatica Extract
    Dipotassium Glycyrrhizate
    Dimethyl Sulfone
    Portulaca Oleracea Extract
    Hizikia Fusiforme Extract
    Glycyrrhiza Glabra (Licorice) Root Extract
    Houttuynia Cordata Extract
    Coptis Japonica Root Extract
    Yeast Beta-Glucan
    Betaine
    Hyaluronic Acid
    Aloe Barbadensis Leaf Extract
    Levulinic Acid
    Olea Europaea (Olive) Fruit Oil
    Camellia Sinensis Leaf Extract
    Opuntia Ficus-Indica Fruit Extract
    Polygonum Cuspidatum Root Extract
    Scutellaria Baicalensis Root Extract
    Camellia Japonica Seed Oil
    Rosmarinus Officinalis (Rosemary) Leaf Extract
    Tocopherol
    Bioflavonoids
    Chamomilla Recutita (Matricaria) Leaf Extract
    Bisabolol
    Rosa Canina Fruit Oil
    Brassica Oleracea Italica (Broccoli) Extract
    Michelia Alba Flower Oil
    Rose Flower Oil
    Cananga Odorata Flower Oil

  • PURPOSE

    protect the skin from dryness and irritation while leaving baby's skin clean and fresh

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Wet baby's skin and hair with warm water. Gently massage over entire body and scalp, then rinse thoroughly.

  • WARNINGS

    for external use only

    do not use if sensitive to any of the ingredients

    discontinue use if signs of irritation or rash appear

    if irritation or rash persists, contact a doctor

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SANDAWHA SOFT BABY WASH 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72289-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1.9345 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PANTHENOL (UNII: WV9CM0O67Z)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72289-0004-1300 g in 1 BOTTLE; Type 0: Not a Combination Product02/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34702/24/2019
    Labeler - SKINCURE INC (557830240)
    Registrant - SKINCURE INC (557830240)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKINCURE INC557830240label(72289-0004) , manufacture(72289-0004)