Label: DIMETHICONE- skin protectant cream

  • NDC Code(s): 68599-0218-1, 68599-0218-4, 68599-0218-8
  • Packager: McKesson
  • 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 September 20, 2021

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

  • 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
    53-CRM4

  • 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
    53-CRM32

  • 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
    53-CRM1000

  • 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
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GINGER (UNII: C5529G5JPQ)  
    CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    ARGININE (UNII: 94ZLA3W45F)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    METHIONINE (UNII: AE28F7PNPL)  
    SERINE (UNII: 452VLY9402)  
    ALANINE (UNII: OF5P57N2ZX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    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)  
    THREONINE (UNII: 2ZD004190S)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)  
    .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)  
    CYSTEINE (UNII: K848JZ4886)  
    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 finalpart34711/04/2019
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions007118524manufacture(68599-0218)
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