TRUEPLUS DIABETICS FOOT CARE CREAM [TRIVIDIA HEALTH, INC.]

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TRUEPLUS DIABETICS FOOT CARE CREAM [TRIVIDIA HEALTH, INC.]
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NDC 56151-682-02, 56151-682-04
Set ID ca481b31-55fc-47c5-ae9e-b7d8db3ce906
Category HUMAN OTC DRUG LABEL
Packager Trividia Health, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active Ingredient

    Dimethicone 5%

  • Purpose

    Skin Protectant

  • Uses

    • Helps relieve, prevent and temporarily protect chafed, chapped, or cracked skin
    • Helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

  • When using this product

    avoid contact with eyes

  • Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Keep out of reach of children

    If swalowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • apply as neded to dry, rough, or problem skin areas
    • reapply as often as needed
  • Inactive Ingredients

    water, ethylhexyl palmitate, glyceryl tribehenate, glycerin, stearic acid, cetearyl alcohol, behenyl erucate, octyldodecyl behenate, caprylyl glycol (and) phenoxyethanol (and) hexylene glycol, tocopheryl acetate, allantoin, carbomer, bisabolol (and) zingiber officinate (ginger) root extract, cholesterol, disodium EDTA, aloe barbadensis leaf juice, sodium hydroxide

  • SPL Unclassified Section

    Manufactured for:

    Trividia Health, Inc.,

    Fort Lauderdale, FL 33309

    1-800-803-6025

    Made in USA

    www.trividiahealth.com

  • 4oz. diabetics foot care cream tube

    4oz tube foot

  • Foot Cream Packet

    2g packet

  • INGREDIENTS AND APPEARANCE
    TRUEPLUS DIABETICS FOOT CARE 
    trueplus diabetics foot care cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56151-682
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GINGER (UNII: C5529G5JPQ)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    OCTYLDODECYL BEHENATE (UNII: BZM9WE5P6F)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE (UNII: V5VD430YW9)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    BEHENYL ERUCATE (UNII: 681898L9A8)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56151-682-04113 g in 1 TUBE; Type 0: Not a Combination Product02/27/2015
    2NDC:56151-682-022 g in 1 PACKET; Type 0: Not a Combination Product02/27/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/27/201508/31/2023
    Labeler - Trividia Health, Inc. (151810868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Trividia Manufacturing Solutions, Inc018927392manufacture(56151-682) , label(56151-682) , pack(56151-682)
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