Label: ESSENTIALS TRIAL KIT kit

  • 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 December 19, 2019

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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 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 (and) phenoxyethanol (and) hexylene glycol, tocopheryl acetate, allantoin, carbomer, disodium EDTA, aloe barbadensis leaf juice, sodium hydroxide

  • kit packet

    kit packet

  • INGREDIENTS AND APPEARANCE
    ESSENTIALS TRIAL KIT 
    essentials trial kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56151-683
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56151-683-041 in 1 KIT; Type 0: Not a Combination Product03/18/201601/30/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 2 g
    Part 1 of 1
    INTENSIVE MOISTURIZING 
    intensive moisturizing cream
    Product Information
    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
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE (UNII: V5VD430YW9)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    OCTYLDODECYL BEHENATE (UNII: BZM9WE5P6F)  
    BEHENYL ERUCATE (UNII: 681898L9A8)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 g in 1 PACKET; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/18/2016
    Labeler - Trividia Health, Inc. (151810868)
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