Label: SPA DRY HEEL FOOT RELIEF- dimethicone cream

  • NDC Code(s): 68828-002-01
  • Packager: Jafra Cosmetics International Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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  • Active ingredient

    Dimethicone 4%

  • Purpose

    Skin protectant

  • Uses

    • Helps prevent and temporarily protects chapped or cracked skin

  • Warning

    For external use only
    When using this product● do not get into eyes
    Stop use and ask a doctor● condition worsens ● symptoms last more than 7 days or clear up and occur again in 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 right away.

  • Direction


    • apply as needed

  • KEEP OUT OF REACH OF CHILDREN

  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, Glycerin, Polyisobutene, Butyrospermum Parkii (Shea) Butter, Stearyl Stearate, Isopropyl Palmitate, Cetearyl Alcohol, Cetyl Alcohol, Di-PPG-3 Myristyl Ether Adipate, Myristyl Myristate, Ceteareth-20, Behenyl Alcohol, Niacinamide, Sodium PCA, Lactic Acid, Olea Europaea (Olive) Fruit Oil, Fragrance, Phenoxyethanol, Xanthan Gum, Caprylyl Glycol, Allantoin, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Phytosterols, Ethylhexylglycerin, Hexylene Glycol, Panthenol, Disodium EDTA

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    SPA DRY HEEL FOOT RELIEF 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYISOBUTYLENE (55000 MW) (UNII: TQ77WR8A02)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    STEARYL STEARATE (UNII: 5WX2EGD0DK)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALLANTOIN (UNII: 344S277G0Z)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-002-011 in 1 CARTON06/01/2022
    1115 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01606/01/2022
    Labeler - Jafra Cosmetics International Inc (041676479)
    Registrant - Jafra Cosmetics International Inc (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-002)
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