Label: TONYMOLY NATURALTH GOAT MILK AQUA WHITENING- 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 January 22, 2016

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  • ACTIVE INGREDIENT

    Active ingredients: Dimethicone 1.0%

  • INACTIVE INGREDIENT

    Inactive ingredients: goat milk extract, cyclopentasiloxane, water, glycerin, propanediol, niacinamide, piper methysticum leaf/root/stem extract, dimethicone/peg-10/15 crosspolymer, polyquaternium-51, sodium chloride, titanium dioxide, arctium lappa root extract, centella asiatica extract, phellinus linteus extract, hydrogenated lecithin, portulaca oleracea extract, fragrance, sodium citrate, chamomilla recutita (matricaria) flower extract, rosmarinus officinalis (rosemary) leaf extract, ethylhexylglycerin, phenoxyethanol, adenosine, triethoxycaprylylsilane, peg-10 dimethicone, peg-9 polydimethylsiloxyethyl dimethicone, calcium pantothenate, amylodextrin, maltodextrin, butylene glycol, hydrolyzed hyaluronic acid, sodium ascorbyl phosphate, pyridoxine hcl, folic acid, ceramide 3, cholesterol, raffinose, silica, tromethamine, palmitoyl pentapeptide-4, panthenol, tocopheryl acetate

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only

    When using this product do not get into eyes

    Stop use and ask a doctor if rash occurs

    Do not use on - deep puncture wounds - animal bites - serious burns

    Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Use

    Use: helps prevent and relieve chapped or cracked skin

  • Directions

    Directions: - clean the skin thoroughly before using - apply in daily skin care routine

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    TONYMOLY NATURALTH GOAT MILK AQUA WHITENING 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-270
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.6 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    goat milk (UNII: XE5K5I4RP7)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-270-0160 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/01/2015
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONYMOLY CO.,LTD688216798manufacture(59078-270)
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