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
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/11

If you are a consumer or patient please visit this version.

  • Active ingredient

    Zinc Oxide 20.0% (3.0% as Calamine)
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  • Purpose

    Skin Protectant Close
  • Keep out of reach of children.

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


    • For the treatment and/or prevention of diaper rash
    • temporarily protects and helps relieve minor skin irritation and itching due to rashes
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  • 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
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  • Directions


    • Cleanse skin with THERATM Moisturizing Body Cleanser or THERATM Foaming 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
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  • Other information

    • Protect from freezing. Avoid excessive heat.
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  • 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. Close
  • Label (4 oz)
  • Label(4 g)
  • Carton
  • INGREDIENTS AND APPEARANCE
    THERA CALAZINC BODY SHIELD 
    zinc oxide paste
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68599-0205
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 200 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    KUKUI NUT OIL  
    ALOE VERA LEAF  
    CALCIUM PANTOTHENATE  
    MALTODEXTRIN  
    NIACINAMIDE  
    PYRIDOXINE HYDROCHLORIDE  
    SILICON DIOXIDE  
    SODIUM ASCORBYL PHOSPHATE  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    LEVOMENOL  
    SAFFLOWER OIL  
    PETROLATUM  
    PHENOXYETHANOL  
    HYALURONATE SODIUM  
    GINGER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68599-0205-4 113 g in 1 TUBE
    2 NDC:68599-0205-1 144 in 1 CARTON
    2 4 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 09/01/2011
    Labeler - McKesson Medical-Surgical Inc. (023904428)
    Registrant - PureTek Corporation (785961046)
    Establishment
    Name Address ID/FEI Business Operations
    PureTek Corporation 785961046 manufacture, label, pack, outsourcing human drug compounding, relabel, repack
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