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| Product NDC Code | 68599-0212 | ||||
|---|---|---|---|---|---|
| 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 | LIQUID | ||||
| 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 1.75%
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 cleanser to damp cloth or to skin/ perineal area and then gently wipe clean No rinsing necessary Apply as needed Apply a protectant cream as necessary
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alanine, Aleurites Moluccana (Kukui) Seed Oil, Aminomethyl Propanol, Arginine, Aspartic Acid, Bisabolol, Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Ceteareth-20, Cetyl Alcohol, Chlorphenesin, Disodium EDTA, Fragrance, ALPHA.-TOCOPHEROL ACETATE Glutamic Acid, Glycerin, Glyceryl Stearate, Glycine, Histidine, Isoleucine, Isopropyl Myristate, Leucine, Lysine, Maltodextrin, Niacinamide (Vitamin B3), PEG-40 Sorbitan Peroleate, Phenoxyethanol, Phenylalanine, Proline, Purified Water, Pyridoxine HCL (Vitamin B6), Serine, Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Stearic Acid, Threonine, Tocopherol Acetate (Vitamin E), Tyrosine, Valine, 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 temporarily protects and helps relieve chapped or cracked skin cleanses, moisturizes, and helps protect skin it can be used on face, body and perineal area
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 Cleanser OCTENYLSUCCINIC ACID LEUCINE SILICON DIOXIDE PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER POLYOXYL 20 CETOSTEARYL ETHER GLYCERYL STEARATE SE PEG-40 SORBITAN PEROLEATE PYRIDOXINE HYDROCHLORIDE WATER SAFFLOWER OIL STEARIC ACID CETYL ALCOHOL ASPARTIC ACID PROLINE GLYCINE TYROSINE PHENYLALANINE ALANINE SODIUM ASCORBYL PHOSPHATE SERINE VALINE THREONINE LYSINE HISTIDINE ARGININE GLUTAMIC ACID .ALPHA.-TOCOPHEROL ACETATE NIACINAMIDE GINGER KUKUI NUT OIL GLYCERIN BUTYLENE GLYCOL CAPRYLYL GLYCOL CHLORPHENESIN ISOPROPYL MYRISTATE MALTODEXTRIN ISOLEUCINE PHENOXYETHANOL CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES CALCIUM PANTOTHENATE DIMETHICONE DIMETHICONE CARBOMER INTERPOLYMER TYPE A (55000 CPS) AMINOMETHYLPROPANOL .BETA.-BISABOLOL MAGNESIUM DISODIUM EDTA
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 68599-0212-8 Thera MOISTURIZING BODY CLEANSER A no-rinse topical cleanser Single Patient Use NET CONTENTS 8 fl. oz (237 mL) MFR # 53-MC8 53-MC8
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