Label: DIMETHICONE- skin protectant cream

  • NDC Code(s): 68599-0218-1, 68599-0218-4, 68599-0218-8
  • Packager: McKesson
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient:
    Dimethicone 1.75%

  • PURPOSE

    Purpose
    Skin Protectant

  • INDICATIONS & USAGE

    Uses
    Temporarily protects and helps relieve chapped or cracked skin
    beneficial for face, hands, body and legs

  • WARNINGS

    Warnings
    For external use only.

    When using this product, do not get into eyes

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • STOP USE

    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
  • 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.

  • DOSAGE & ADMINISTRATION

    Directions
    Apply cream liberally as needed

  • OTHER SAFETY INFORMATION

    Store at 40-95ºF (4-35ºC).

  • INACTIVE INGREDIENT

    Inactive ingredients
    Alanine, Aleurites Moluccanus (Kukui) Seed Oil, Aloe
    Barbadensis Leaf Juice, Arginine, Aspartic Acid, Bisabolol,
    Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl
    Glycol, Carthamus Tinctorius (Safflower) Oleosomes,
    Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol,
    Chlorphenesin, Dimethicone Crosspolymer, Dimethicone,
    Disodium EDTA, Fragrance, Glutamic Acid, Glycerin, Glyceryl
    Stearate, Glycine, Histidine, Isoleucine, Leucine, Lysine,
    Maltodextrin, Niacinamide (Vitamin B3), PEG-100 Stearate,
    Phenoxyethanol, Phenylalanine, Proline, Pyridoxine HCl
    (Vitamin B6), Serine, Silica, Sodium Ascorbyl Phosphate
    (Vitamin C), Sodium Hyaluronate, Sodium Starch
    Octenylsuccinate, Stearic Acid, Threonine, Tocopheryl Acetate
    (Vitamin E), Triethanolamine, Tyrosine, Valine, Water, Zingiber
    Officinale (Ginger) Root Extract

  • QUESTIONS

    Questions?
    Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL


    NDC 68599-0218-4
    McKesson
    Thera
    MOISTURIZING BODY CREAM
    Everyday moisturizer and skin conditioner.
    Single Patient Use
    NET CONTENTS 4 fl oz (118 mL)
    MFR # 53-CRM4
    each

  • PRINCIPAL DISPLAY PANEL


    NDC 68599-0218-8
    McKesson
    Thera
    MOISTURIZING BODY CREAM
    Everyday moisturizer and skin conditioner.
    Single Patient Use
    NET CONTENTS 32 fl oz (946 mL)
    MFR # 53-CRM32
    each

  • PRINCIPAL DISPLAY PANEL


    NDC 68599-0218-1
    McKesson
    Thera
    MOISTURIZING BODY CREAM
    Refill for McKesson Pump Dispenser MFR # 53-1000.
    NET CONTENTS 1000 mL (34 fl. oz.)
    MFR # 53-CRM1000
    each

  • INGREDIENTS AND APPEARANCE
    DIMETHICONE 
    skin protectant cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0218
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE17.5 ug  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GINGER (UNII: C5529G5JPQ)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    ARGININE (UNII: 94ZLA3W45F)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    SERINE (UNII: 452VLY9402)  
    ALANINE (UNII: OF5P57N2ZX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CARTHAMUS TINCTORIUS FLOWER OIL (UNII: SDQ136WIM5)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VALINE (UNII: HG18B9YRS7)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    LYSINE (UNII: K3Z4F929H6)  
    HISTIDINE (UNII: 4QD397987E)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    GLYCINE (UNII: TE7660XO1C)  
    LEUCINE (UNII: GMW67QNF9C)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    TYROSINE (UNII: 42HK56048U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-0218-4118 mg in 1 TUBE; Type 0: Not a Combination Product11/04/2019
    2NDC:68599-0218-8946 mg in 1 BOTTLE; Type 0: Not a Combination Product11/04/2019
    3NDC:68599-0218-11000 mg in 1 BAG; Type 0: Not a Combination Product11/04/201901/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/04/2019
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions007118524manufacture(68599-0218)
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