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

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 August 17, 2021

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

View All Sections
  • 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 TM Moisturizing Body Cleanser or THERA TM 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
  • 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

    53-CZ4

  • Label(4 g)

    NDC 68599-0205-1

    Thera

    Calazinc Body Shield

    Net Weight 4 g (0.14 oz)

    MFR# 53-CZ4G

    53-CZ4G

  • Box

    NDC 68599-0205-1

    Thera

    Calazinc Body Shield

    Net Weight 4 g (0.14 oz)

    MFR# 53-CZ4G

    53-CZ4G Box

  • 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
    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)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GINGER (UNII: C5529G5JPQ)  
    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 finalpart34709/01/2011
    Labeler - McKesson Medical-Surgical Inc. (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions007118524manufacture(68599-0205)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!