Thera Calazinc Body Shield Paste
FDA Label NDC 68599-0205

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson Medical-surgical Inc. for the product Thera Calazinc Body Shield (NDC 68599-0205). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children., uses, warnings, do not use on, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 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

Other Information

  • Protect from freezing. Avoid excessive heat.

Inactive Ingredient

Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, SAFFLEXTM (Consisting of: Calcium Pantothenate (Vitamin B5), Maltodexdrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), 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.

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