Label: THERA CALAZINC BODY SHIELD- zinc oxide paste

  • NDC Code(s): 68599-0205-1, 68599-0205-4
  • Packager: McKesson Medical-Surgical Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 17, 2024

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  • Active ingredient

    • Zinc Oxide 20.0% (3.0% as Calamine)
  • 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 minor skin irritation and itching due to rashes
  • 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


    • Cleanse skin with THERA TMMoisturizing Body Cleanser or THERA TMFoaming Body Cleanser
    • Apply paste to area as needed
    • For G-tubes, cleanse as above, apply thin layer and secure with drain sponge or product as directed
  • Other information

    • Protect from freezing. Avoid excessive heat.
  • INACTIVE INGREDIENT

    • Aleurites Moluccana Seed Oil,
    • Aloe Barbadensis (Aloe Vera) Leaf Juice,
    • SAFFLEX TM(Consisting of: Calcium Pantothenate (Vitamin B 5),
    • Maltodexdrin,
    • Niacinamide (Vitamin B 3),
    • Pyridoxine HCl (Vitamin B 6),
    • Silica,
    • Sodium Ascorbyl Phosphate (Vitamin C),
    • Sodium Starch Octenylsuccinate,
    • Tocopheryl Acetate (Vitamin E)), Bisabolol,
    • Carthamus Tinctorius (Safflower) Olesomes,
    • Carthamus Tinctorius (Safflower) Seed Oil,
    • Lavender Ylang Fragrance,
    • Modified Corn Starch,
    • Pentaerythrityl Tetra-di-t-Butyl Hydroxyhydrocinnamate,
    • Petrolatum,
    • Phenoxyethanol,
    • Sodium Hyaluronate,
    • Zingiber Officinale (Ginger) Root Extract.
  • Label (4 oz)

    NDC 68599-0205-4

    Thera

    Calazinc Body Shield

    Net Contents 4 fl oz (113 mL)

    MFR# 53-CZ4

    each

  • Label(4 g)

    NDC 68599-0205-1

    Thera

    Calazinc Body Shield

    Net Weight 4 g (0.14 oz)

    MFR# 53-CZ4G

    box

    each

  • INGREDIENTS AND APPEARANCE
    THERA CALAZINC BODY SHIELD 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HISTIDINE (UNII: 4QD397987E)  
    TYROSINE (UNII: 42HK56048U)  
    LYSINE (UNII: K3Z4F929H6)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GINGER (UNII: C5529G5JPQ)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    ALANINE (UNII: OF5P57N2ZX)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    VALINE (UNII: HG18B9YRS7)  
    WATER (UNII: 059QF0KO0R)  
    SERINE (UNII: 452VLY9402)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    OCTENYLSUCCINIC ACID (UNII: 12UZE4X73L)  
    GLYCINE (UNII: TE7660XO1C)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    ZEA MAYS WHOLE (UNII: 1G5HNE09V8)  
    LEUCINE (UNII: GMW67QNF9C)  
    ARGININE (UNII: 94ZLA3W45F)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    THREONINE (UNII: 2ZD004190S)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-0205-4113 g in 1 TUBE; Type 0: Not a Combination Product09/01/2011
    2NDC:68599-0205-1144 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(68599-0205)
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