Label: DIMETHICONE- body cleanser liquid

  • 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 22, 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
    • 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, ALPHA.-TOCOPHEROL ACETATE Glutamic Acid, Glycerin, Glyceryl Stearate, Glycine, Histidine, Isoleucine, Isopropyl Myristate, Leucine,
    Lysine, Maltodextrin, Niacinamide (Vitamin B3), PEG-40 Sorbitan Peroleate, Phenoxyethanol, Phenylalanine, Proline, Purified Water, Pyridoxine HCL (Vitamin B6), Serine,
    Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Stearic Acid, Threonine, Tocopherol Acetate (Vitamin E), Tyrosine,
    Valine, 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

    53-MC8

  • 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 finalpart34708/13/2019
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions007118524manufacture(68599-0212)
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