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
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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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

    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

    • Protect from freezing. Avoid excessive heat.
  • Inactive ingredients

    • Aleurites Moluccana Seed Oil,
    • Aloe Barbadensis (Aloe Vera) Lead Juice,
    • SAFFLEX TM(Consisting of:
    • Calcium Pantothenate (Vitamin B 5),
    • Maltodextrin, Niacinamide (Vitamin B 3),
    • Pyridoxine HCl (Vitamin B 6),
    • Silica,
    • Sodium Ascorbyl Phosphate (Vitamin C),
    • Sodium Starch Octenylsuccinate,
    • Tocopheryl Acetate (Vitamin E)),
    • Bisabolol,
    • C12-13 Pareth-23,
    • C12-13 Pareth-3,
    • Carthamus Tinctorius (Safflower) Oleosomes,
    • Carthamus Tinctorius (Safflower) Seed Oil,
    • Cetyl Dimethicone,
    • Clyclopentasiloxane,
    • Dicaprylyl Carbonate,
    • Dimethiconol,
    • Divinyldimethicone/Dimethicone Copolymer,
    • Lavender Ylang Fragrance,
    • PEG/PPG-18/18 Dimethicone,
    • Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate,
    • Phenoxyethanol,
    • Propylene Glycol,
    • Propylheptyl Caprylate,
    • Purified Water,
    • Sodium Chloride,
    • Sodium Hyaluronate,
    • Zingiber Officinal (Ginger) Root Extract.
  • Label (4 oz)

    NDC 68599-0204-4

    Thera

    Moisturizing Body Shield

    Net Contents 4 fl oz (118 mL)

    MFR# 53-MS4

    53-MS4

  • Label (4g)

    53-MS4G boxNDC 68599-0204-1

    Thera

    Moisturizing Body Shield

    Net Contents 4 g (0.14 oz)

    MFR# 53-MS4G

    53-MS4g each

  • 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
    KUKUI NUT (UNII: J87WJ3E7VW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GINGER (UNII: C5529G5JPQ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    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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