Label: DIABETICS INTENSIVE MOISTURIZING 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 16, 2022

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  • Active Ingredients

    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 swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    apply as needed 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, phenoxyethanol, hexylene glycol, tocopheryl acetate, allantoin, carbomer, disodium EDTA, aloe barbadensis leaf juice, sodium hydroxide

  • 4oz.Intensive tube front

    tbes

  • intensive packet

    intensive packet

  • INGREDIENTS AND APPEARANCE
    DIABETICS INTENSIVE MOISTURIZING 
    diabetics intensive moisturizing cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56151-681
    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
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE (UNII: V5VD430YW9)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    BEHENYL ERUCATE (UNII: 681898L9A8)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    OCTYLDODECYL BEHENATE (UNII: BZM9WE5P6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56151-681-04113 g in 1 TUBE; Type 0: Not a Combination Product02/27/2015
    2NDC:56151-681-022 g in 1 PACKET; Type 0: Not a Combination Product06/12/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/27/2015
    Labeler - Trividia Health, Inc. (151810868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Trividia Manufacturing Solutions, Inc018927392manufacture(56151-681) , label(56151-681) , pack(56151-681)
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