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| Product NDC Code | 68599-0213 | ||||
|---|---|---|---|---|---|
| Drug Name | Dimethicone |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part347 | ||||
| Labeler Name | McKesson | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Dimethicone 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 Cleanse skin with Thera Moisturizing Body Cleanser or Thera Foaming Body Cleanser Apply cream liberally until entire area is covered Apply as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Purified Water, Glyceryl Stearate, PEG 100 Stearate, Stearic Acid, Aleurites Moluccana Seed Oil, Cetyl Alcohol, Glycerin, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Dimethicone Crosspolymer, Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), Disodium EDTA, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Bisabolol, Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Triethanolamine
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.Dimethicone Body Shield VALINE PHENYLALANINE CYSTEINE GLYCERYL MONOSTEARATE KUKUI NUT OIL SAFFLOWER OIL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) CALCIUM PANTOTHENATE SILICON DIOXIDE CETYL ALCOHOL SODIUM ASCORBYL PHOSPHATE OCTENYLSUCCINIC ACID ALOE VERA LEAF CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES CAPRYLYL GLYCOL PROLINE GLYCINE ARGININE ASPARTIC ACID ALANINE LEUCINE TYROSINE METHIONINE TROLAMINE GLYCERIN WATER MALTODEXTRIN PYRIDOXINE HYDROCHLORIDE HYALURONATE SODIUM GINGER LYSINE THREONINE GLUTAMIC ACID ISOLEUCINE PEG-100 STEARATE STEARIC ACID BUTYLENE GLYCOL NIACINAMIDE .ALPHA.-TOCOPHEROL ACETATE EDETATE DISODIUM ANHYDROUS CHLORPHENESIN HISTIDINE SERINE PHENOXYETHANOL LEVOMENOL DIMETHICONE DIMETHICONE
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.NDC 68599-0213-4 McKesson Thera DIMETHICONE BODY SHIELD Provides mild skin protection against irritation from chapped or cracked skin. Single Patient Use NET CONTENTS 4 fl oz (118 mL) MFR # 53-DS4 53-DS4
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Store at 40-95ºF (4-35ºC)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-777-4908
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
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. When using this product do not get into eyes Do not use on deep or puncture wounds animal bites serious burns
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