Label: SKINFIX HAND REPAIR- oatmeal cream

  • NDC Code(s): 61328-106-11, 61328-106-13
  • Packager: Skinfix, Inc.
  • 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 24, 2022

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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

    30 ml

    Skinfix_Hand_Repair_Cream_v8_30.jpg

    90 ml

    Skinfix_Hand_Repair_Cream_v8_90.jpg

  • INGREDIENTS AND APPEARANCE
    SKINFIX HAND REPAIR 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-106
    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: G0R4UBI2ZZ)  
    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:61328-106-1390 mL in 1 TUBE; Type 0: Not a Combination Product07/02/2014
    2NDC:61328-106-1130 mL in 1 TUBE; Type 0: Not a Combination Product09/23/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/02/2014
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)
    Establishment
    NameAddressID/FEIBusiness Operations
    SIGAN INDUSTRIES INC255106239manufacture(61328-106)
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