Label: AFTER CARE- dimethicone cream

  • NDC Code(s): 46783-004-04, 46783-004-15, 46783-004-20, 46783-004-30
  • Packager: Merz North America
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Dimethicone 4%

  • Purpose

    Skin protectant

  • Uses

    • Helps prevent, temporarily protect and relieve chapped or cracked skin.
  • Warnings

    For external use only.

    When using this product

    • Do not get into eyes

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms last 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 right away.

  • Directions

    • Apply as needed.
  • Inactive ingredients

    Water (Aqua), Octyl-Dodecanol, Petrolatum, Hydrogenated Polyisobutene, Glyceryl Stearate, Decyl Oleate, Glycerin, Propylene Glycol, Wheat Germ (Triticum Vulgare) Oil, Stearic Acid, Cetyl Alcohol, Ceteareth-20, Processed Skin Proteins (PSP(R)), Myreth-3 Myristate, Ceteareth-12, Cetearyl Alcohol, Cetyl Palmitate, Wild Yam (Dioscorea Villosa) Root Extract, Borage (Borago Officinalis) Seed Oil, Tocopheryl Acetate, Glycosphingolipids, Carbomer, Methylparaben, Sodium Methylparaben, Ethylparaben, BHT, Phenoxyethanol, Disodium EDTA, Sodium Hydroxide, Propylparaben.

  • Other information

    • Protect this product from excessive heat and direct sun.
  • SPL UNCLASSIFIED SECTION

    Distributed in the USA
    by Merz North America, Inc.
    Raleigh, NC 27615

  • PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton

    aftercare

    POST-TREATMENT
    SOOTHING CREAM

    NEOCUTIS®

    PRINCIPAL DISPLAY PANEL - 15 ML Bottle Carton
  • INGREDIENTS AND APPEARANCE
    AFTER CARE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46783-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DECYL OLEATE (UNII: ZGR06DO97T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    HUMAN SKIN PROTEINS, PARTIALLY HYDROLYZED (UNII: G9813R29TW)  
    MYRETH-3 MYRISTATE (UNII: O2C2MN32O6)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46783-004-151 in 1 CARTON04/01/2019
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:46783-004-201 in 1 CARTON04/01/2019
    2200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:46783-004-044 mL in 1 TUBE; Type 0: Not a Combination Product06/11/2019
    4NDC:46783-004-301 in 1 CARTON10/02/2023
    430 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01604/01/2019
    Labeler - Merz North America (028147846)
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