Label: DIMETHICONE- body shield cream

  • 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 January 14, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient
    Dimethicone 5%

  • PURPOSE

    Purpose
    Skin Protectant

  • INDICATIONS & USAGE

    Uses
    for the treatment and/or prevention of diaper rash
    temporarily protects and helps relieve chapped or cracked skin

  • 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

    • Cleanse skin with Thera Moisturizing Body Cleanser or Thera Foaming Body Cleanser
    • Apply cream liberally until entire area is covered
    • Apply as needed
  • OTHER SAFETY INFORMATION


    Store at 40-95ºF (4-35ºC)

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Purified Water, Glyceryl Stearate, PEG 100 Stearate, Stearic Acid, Aleurites Moluccana Seed Oil,
    Cetyl Alcohol, Glycerin, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil,
    Dimethicone Crosspolymer, 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), Disodium EDTA, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract,
    Zingiber Officinale (Ginger) Root Extract, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance,
    Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Bisabolol, Lysine, Histidine, Arginine, Aspartic Acid,
    Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine,
    Tyrosine, Phenylalanine, Cysteine, Triethanolamine

  • QUESTIONS

    Questions?
    Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-0213-4
    McKesson
    Thera
    DIMETHICONE BODY SHIELD
    Provides mild skin protection against irritation from chapped or cracked skin.
    Single Patient Use
    NET CONTENTS 4 fl oz (118 mL)
    MFR # 53-DS4

    53-DS4

  • INGREDIENTS AND APPEARANCE
    DIMETHICONE 
    body shield cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE50 ug  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    VALINE (UNII: HG18B9YRS7)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    CYSTEINE (UNII: K848JZ4886)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    GLYCINE (UNII: TE7660XO1C)  
    ARGININE (UNII: 94ZLA3W45F)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    ALANINE (UNII: OF5P57N2ZX)  
    LEUCINE (UNII: GMW67QNF9C)  
    TYROSINE (UNII: 42HK56048U)  
    METHIONINE (UNII: AE28F7PNPL)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GINGER (UNII: C5529G5JPQ)  
    LYSINE (UNII: K3Z4F929H6)  
    THREONINE (UNII: 2ZD004190S)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    HISTIDINE (UNII: 4QD397987E)  
    SERINE (UNII: 452VLY9402)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-0213-4118 mg in 1 BOTTLE; Type 0: Not a Combination Product08/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/12/2019
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions007118524manufacture(68599-0213)
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