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| Product NDC Code | 68599-0218 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | ||||||
| RxCUI drug identifier | 1148394 | ||||||
| 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 cream liberally as needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Purified Water, Aleurites Moluccana Seed Oil, Stearic Acid, Cetyl Alcohol, Glycerin, Glyceryl Stearate, PEG 100 Stearate, Carthamus Tinctorius (Safflower) Seed Oil, Dimethicone Crosspolymer, Butylene Glycol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Carthamus Tinctorius (Safflower) Oleosomes, 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), Bisabolol, Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Fragrance, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Disodium EDTA, 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 Temporarily protects and helps relieve chapped or cracked skin beneficial for face, hands, body and legs
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 Skin Protectant KUKUI NUT OIL STEARIC ACID CETYL ALCOHOL GINGER CARTHAMUS TINCTORIUS FLOWER BUD CALCIUM PANTOTHENATE PYRIDOXINE HYDROCHLORIDE ARGININE ASPARTIC ACID PROLINE METHIONINE SERINE ALANINE GLYCERIN GLYCERYL MONOSTEARATE PEG-100 STEARATE CARTHAMUS TINCTORIUS FLOWER OIL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) BUTYLENE GLYCOL THREONINE HYALURONATE SODIUM LEVOMENOL EDETATE DISODIUM ANHYDROUS WATER NIACINAMIDE OCTENYLSUCCINIC ACID .ALPHA.-TOCOPHEROL ACETATE VALINE ISOLEUCINE PHENYLALANINE PHENOXYETHANOL CAPRYLYL GLYCOL MALTODEXTRIN LYSINE HISTIDINE GLUTAMIC ACID GLYCINE LEUCINE CYSTEINE ALOE VERA LEAF SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE TYROSINE CHLORPHENESIN TROLAMINE 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 68599-0218-4 McKesson Thera MOISTURIZING BODY CREAM Everyday moisturizer and skin conditioner. Single Patient Use NET CONTENTS 4 fl oz (118 mL) MFR # 53-CRM4 53-CRM4
NDC 68599-0218-8 McKesson Thera MOISTURIZING BODY CREAM Everyday moisturizer and skin conditioner. Single Patient Use NET CONTENTS 32 fl oz (946 mL) MFR # 53-CRM32 53-CRM32
NDC 68599-0218-1 McKesson Thera MOISTURIZING BODY CREAM Refill for McKesson Pump Dispenser MFR # 53-1000. NET CONTENTS 1000 mL (34 fl. oz.) MFR # 53-CRM1000 53-CRM1000
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