Label: THERA MOISTURIZING BODY SHIELD- dimethicone cream

  • NDC Code(s): 68599-0204-1, 68599-0204-4
  • Packager: McKesson Medical-Surgical Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 18, 2024

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  • Active ingredient

    • Dimethicone 1.5%
  • Purpose

    • Skin Protectant
  • Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Uses


    • For the treatment and/or prevention of diaper rash
    • Temporarily protects and helps relieve chapped or cracked skin
  • Warnings

    • For external use only
    • Protect from freezing. Avoid excessive heat.

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • do not get into eyes

    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
  • Directions

    • Apply liberally as needed
  • Inactive ingredients

    Inactive ingredients
    Alanine, Aleurites Moluccana (Kukui) Seed Oil, Aloe
    Barbadensis Leaf Juice, Arginine, Aspartic Acid, Butylene
    Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl Glycol,
    Carthamus Tinctorius (Safflower) Oleosomes, Carthamus
    Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Cetyl
    Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone,
    Chlorphenesin, Dicaprylyl Carbonate, Dimethicone
    Crosspolymer, Fragrance, Glutamic Acid, Glycine, Hexyl
    Laurate, Histidine, Isoleucine, Leucine, Lysine, Maltodextrin,
    Niacinamide (Vitamin B3), Phenoxyethanol, Phenylalanine,
    Polyglyceryl-4 Isostearate, Proline, Propylene Glycol,
    Propylheptyl Caprylate, Pyridoxine HCL (Vitamin B6), Serine,
    Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium
    Chloride, Sodium Hyaluronate, Sodium Starch
    Octenylsuccinate, Threonine, Tocopheryl Acetate (Vitamin
    E), Tyrosine, Valine, Water

  • Label (4 oz)

    NDC 68599-0204-4

    Thera

    Moisturizing Body Shield

    Net Contents 4 fl oz (118 mL)

    MFR# 53-MS4

    each

  • Label (4g)

    NDC 68599-0204-1

    Thera

    Moisturizing Body Shield

    Net Contents 4 g (0.14 oz)

    MFR# 53-MS4G

    eachbox

  • INGREDIENTS AND APPEARANCE
    THERA MOISTURIZING BODY SHIELD 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    THREONINE (UNII: 2ZD004190S)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LYSINE (UNII: K3Z4F929H6)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    GLYCINE (UNII: TE7660XO1C)  
    SERINE (UNII: 452VLY9402)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    HISTIDINE (UNII: 4QD397987E)  
    ALANINE (UNII: OF5P57N2ZX)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    TYROSINE (UNII: 42HK56048U)  
    VALINE (UNII: HG18B9YRS7)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ARGININE (UNII: 94ZLA3W45F)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    WATER (UNII: 059QF0KO0R)  
    LEUCINE (UNII: GMW67QNF9C)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-0204-4113 g in 1 TUBE; Type 0: Not a Combination Product09/01/2011
    2NDC:68599-0204-1144 in 1 CARTON09/01/2011
    24 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/01/2011
    Labeler - McKesson Medical-Surgical Inc. (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions007118524manufacture(68599-0204)
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