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Thera calazinc body shield - Medication Information

Product NDC Code 68599-0205
Drug Name

Thera calazinc body shield

Type Brand
Active Ingredients
Zinc oxide 200 mg/g
Route TOPICAL
Dosage Form PASTE
Application Number part347
Labeler Name McKesson Medical-Surgical Inc.
Packages
Package NDC Code Description
68599-0205-1 144 packet in 1 carton (68599-0205-1) / 4 g in 1 packet
68599-0205-4 113 g in 1 tube (68599-0205-4)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc Oxide 20.0% (3.0% as Calamine)

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses For the treatment and/or prevention of diaper rash temporarily protects and helps relieve minor skin irritation and itching due to rashes

Purpose

Information about the drug product’s indications for use.
Purpose Skin Protectant

Spl product data elements

Usually a list of ingredients in a drug product.
THERA Calazinc Body Shield Zinc Oxide 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 ZINC OXIDE ZINC OXIDE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
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

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on deep or puncture wounds animal bites serious burns

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product do not get into eyes

Storage and handling

Information about safe storage and handling of the drug product.
Other information Protect from freezing. Avoid excessive heat.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API