Label: TONYMOLY PANDAS DREAM WHITE HAND- niacinamide cream

  • 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 20, 2016

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  • ACTIVE INGREDIENT

    Active ingredients: Niacinamide 2.0%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Butyrospermum Parkii (Shea) Butter, Glycerin, Cetyl Ethylhexanoate, Cetearyl Alcohol, Butylene Glycol, Glyceryl Stearate, Polysorbate 60, PEG/PPG-17/6 Copolymer, Cyclopentasiloxane, Hydrogenated Polydecene, Beeswax, Cyclohexasiloxane, Palmitic Acid, Stearic Acid, Xanthan Gum, Dimethicone, PEG-100 Stearate, Fragrance, Phenoxyethan ol, Tocopheryl Acetate, Polyacrylate-13, Chlorphenesin, Polyisobutene, Ethylhexylglycerin, Sorbitan Stearate, Caprylyl Glycol, Honey Extract, Phyllostachis Bambusoides Juice, Sorbitan Isostearate, Polysorbate 20, Disodium EDTA, Alcohol, Polyglutamic Acid, Citric Acid

  • 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 routined

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of package

  • INGREDIENTS AND APPEARANCE
    TONYMOLY PANDAS DREAM WHITE HAND 
    niacinamide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.6 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-220-0130 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2015
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONYMOLY CO.,LTD688216798manufacture(59078-220)