Label: SKINFIX HAND REPAIR- oatmeal cream

  • NDC Code(s): 54291-035-01, 54291-035-02, 54291-035-03, 54291-035-04, view more
    54291-035-05, 54291-035-06
  • Packager: Canadian Custom Packaging Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 10, 2024

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  • Active Ingredients

    Colloidal Oatmeal 1%

  • Purpose

    Skin Protectant

  • Warnings

    For external use only.

    When using this product Avoid contact with eyes.

    Stop use and ask a doctor if condition worsens.

    If symptoms last more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • Uses

    Temporarily protects dry cracked skin and helps relieve monor skin irritations and itching due to eczema.

  • Directions

    Apply cream liberally as needed, especially after hand washing.

  • Inactive Ingredients:

    allantoin, aloe barbadensis leaf juice, avena sativa kernel oil, beeswax, butyrospermum parkii (shea) butter, calendula officinalis extract, capyrlic/capric triglyceride, caprylyl-caprylate/caprate, chamomilla recutita (matricaria) flower extract, citric acid, ethylhexylglycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, oryza sativa (rice) bran extract, petrolatum, phenoxyethanol, polyglyceryl-2-stearate, potassium sorbate, prunus amygdalus dulcis (sweet almond) oil, rosmarinus officinalis (rosemary) leaf extract, simmondsia chinensis (jojoba) seed oil, stearyl alcohol, tocopherol, trisodium ethylenediamine disuccinate, water (aqua), xanthan gum

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SKINFIX HAND REPAIR 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54291-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
    MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54291-035-0290 mL in 1 TUBE; Type 0: Not a Combination Product07/02/2014
    2NDC:54291-035-0360 mL in 1 TUBE; Type 0: Not a Combination Product09/23/2016
    3NDC:54291-035-0430 mL in 1 TUBE; Type 0: Not a Combination Product09/23/2016
    4NDC:54291-035-0110 mL in 1 TUBE; Type 0: Not a Combination Product03/15/2017
    5NDC:54291-035-05150 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2018
    6NDC:54291-035-06148 mL in 1 PACKAGE; Type 0: Not a Combination Product12/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/02/2014
    Labeler - Canadian Custom Packaging Company (207062514)
    Registrant - Canadian Custom Packaging Company (207062514)
    Establishment
    NameAddressID/FEIBusiness Operations
    Canadian Custom Packaging Company207062514manufacture(54291-035)
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