Label: DIMETHICONE- body cleanser liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 14, 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
    • cleanses, moisturizes, and helps protect skin
    • it can be used on face, body and perineal area
  • 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 cleanser to damp cloth or to skin/ perineal area and then gently wipe clean
    • No rinsing necessary
    • Apply as needed
    • Apply a protectant cream as necessary
  • OTHER SAFETY INFORMATION

    Store at 40-95ºF (4-35ºC)

  • INACTIVE INGREDIENT

    Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate
    Crosspolymer, Alanine, Aleurites
    Moluccana (Kukui) Seed Oil,
    Aminomethyl Propanol, Arginine, Aspartic
    Acid, Bisabolol, Butylene Glycol, Calcium
    Pantothenate (Vitamin B5), Caprylyl
    Glycol, Carthamus Tinctorius (Safflower)
    Oleosomes, Carthamus Tinctorius
    (Safflower) Seed Oil, Ceteareth-20, Cetyl
    Alcohol, Chlorphenesin, Disodium EDTA,
    Fragrance, Glutamic Acid, Glycerin,
    Glyceryl Stearate, Glycine, Histidine,
    Isoleucine, Isopropyl Myristate, Leucine,
    Lysine, Maltodextrin, Niacinamide
    (Vitamin B3), PEG-40 Sorbitan Peroleate,
    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), Tyrosine, Valine, Water, Zingiber
    Officinale (Ginger) Root Extract

  • QUESTIONS

    Questions?
    Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-0212-8
    Thera
    MOISTURIZING BODY CLEANSER
    A no-rinse topical cleanser
    Single Patient Use
    NET CONTENTS 8 fl. oz (237 mL)
    MFR # 53-MC8

    each

  • INGREDIENTS AND APPEARANCE
    DIMETHICONE 
    body cleanser liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0212
    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)  
    LEUCINE (UNII: GMW67QNF9C)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-40 SORBITAN PEROLEATE (UNII: 276639YRZL)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    WATER (UNII: 059QF0KO0R)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    GLYCINE (UNII: TE7660XO1C)  
    TYROSINE (UNII: 42HK56048U)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    ALANINE (UNII: OF5P57N2ZX)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SERINE (UNII: 452VLY9402)  
    VALINE (UNII: HG18B9YRS7)  
    THREONINE (UNII: 2ZD004190S)  
    LYSINE (UNII: K3Z4F929H6)  
    HISTIDINE (UNII: 4QD397987E)  
    ARGININE (UNII: 94ZLA3W45F)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GINGER (UNII: C5529G5JPQ)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-0212-8237 mg in 1 BOTTLE; Type 0: Not a Combination Product08/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/13/2019
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions007118524manufacture(68599-0212)
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