Label: TONYMOLY PANDAS DREAM WHITE HAND CREAM- glycerin 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 February 11, 2016

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  • Active Ingredients

    Glycerin 7.00%, Dimethicone 0.50%

  • Purpose

    Skin Protectant

  • Uses

    Helps prevent and temporarily protects chafed, chapped or cracked skin.

  • Warnings

    For external use only.

  • Do not use

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Stop use and ask a doctor if

    • Condition wornsens
    • Symptoms persist more than 7 days or clear up and occur again within a few days
  • When using this product

    • Avoid contact with eyes, If contact occurs, rinse eyes thoroughly with water
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply as needed.

  • Inactive Ingredients

    Water, Butyrospermum Parkii (Shea) Butter, Cetyl Ethylhexanoate, Cetearyl Alcohol, Butylene Glycol, Niacinamide, Glyceryl Stearate, Polysorbate 60, PEG/PPG-17/6 Copolymer, Cyclopentasiloxane, Hydrogenated Polydecene, Beeswax, Cyclohexasiloxane, Palmitic Acid, Stearic Acid, Xanthan Gum, PEG-100 Stearate, Fragrance, Phenoxyethanol, 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

  • Questions?

    Call 1-848-200-2230

  • Package Label

    panda dream white hand cream

  • INGREDIENTS AND APPEARANCE
    TONYMOLY PANDAS DREAM WHITE HAND CREAM 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.15 g  in 30 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.1 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HONEY (UNII: Y9H1V576FH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYGALIC ACID (UNII: XCC6WEA55L)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-152-011 in 1 BOX01/19/2016
    130 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/14/2016
    Labeler - Tonymoly Co., Ltd. (688216798)
    Registrant - Tonymoly Co., Ltd. (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmecca688830827manufacture(59078-152)
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