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| Product NDC Code | 68599-0204 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Thera moisturizing body shield |
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| Type | Brand | ||||||
| Pharm Class | Skin Barrier Activity [PE] | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| RxCUI drug identifier | 309917 | ||||||
| Application Number | M016 | ||||||
| Labeler Name | McKesson Medical-Surgical Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Dimethicone 1.5%
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 Apply liberally as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Inactive ingredients Alanine, Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf Juice, Arginine, Aspartic Acid, Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Dicaprylyl Carbonate, Dimethicone Crosspolymer, Fragrance, Glutamic Acid, Glycine, Hexyl Laurate, Histidine, Isoleucine, Leucine, Lysine, Maltodextrin, Niacinamide (Vitamin B3), Phenoxyethanol, Phenylalanine, Polyglyceryl-4 Isostearate, Proline, Propylene Glycol, Propylheptyl Caprylate, Pyridoxine HCL (Vitamin B6), Serine, Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Chloride, Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Threonine, Tocopheryl Acetate (Vitamin E), Tyrosine, Valine, Water
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 chapped or cracked skin
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 Moisturizing Body Shield Dimethicone GLUTAMIC ACID THREONINE CHLORPHENESIN LYSINE POLYGLYCERYL-4 ISOSTEARATE GLYCINE SERINE HEXYL LAURATE HISTIDINE ALANINE SAFFLOWER OIL CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) BUTYLENE GLYCOL SILICON DIOXIDE HYALURONATE SODIUM ISOLEUCINE TYROSINE VALINE KUKUI NUT OIL ALOE VERA LEAF CALCIUM PANTOTHENATE MALTODEXTRIN NIACINAMIDE PYRIDOXINE HYDROCHLORIDE SODIUM ASCORBYL PHOSPHATE .ALPHA.-TOCOPHEROL ACETATE, DL- ARGININE CARTHAMUS TINCTORIUS SEED OLEOSOMES CAPRYLYL GLYCOL DICAPRYLYL CARBONATE PHENOXYETHANOL PROPYLENE GLYCOL PROPYLHEPTYL CAPRYLATE WATER LEUCINE PHENYLALANINE SODIUM CHLORIDE DIMETHICONE DIMETHICONE PROLINE CETYL ALCOHOL ASPARTIC ACID
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 68599-0204-4 Thera Moisturizing Body Shield Net Contents 4 fl oz (118 mL) MFR# 53-MS4 each
Label (4g) NDC 68599-0204-1 Thera Moisturizing Body Shield Net Contents 4 g (0.14 oz) MFR# 53-MS4G each 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
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 Protect from freezing. Avoid excessive heat. 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