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Product NDC Code | 79974-203 | ||||||||
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Drug Name | Curefini |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | CREAM | ||||||||
RxCUI drug identifier | 1043075 | ||||||||
Application Number | part347 | ||||||||
Labeler Name | Miramar Cosmetics, Inc DBA Miramar Lab | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Petrolatum.............30.00%
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 daily over the affected area, with soft massages to ease absorption. Repeat application as many times as needed to keep skin permanently moisturized.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aqua (Deionized Water), Beeswax, Cetearyl Alcohol, Cetearyl Olivate, Cetearyl Glucoside, Chamomilla Recutitta (Chamomile) Extract, Chamomilla Recutitta (Chamomile) Oil, Cocamidopropyl Betaine, Ethylhexylglycerin, Gadi Lecur (Cod Liver) Oil, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E).
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 temporary protection of minor cuts, scrapes and burns. • For temporary protection of cracked and chapped skin. • Helps protect from the drying effects of wind and cold weather.
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.CUREFINI Petrolatum PETROLATUM PETROLATUM WATER YELLOW WAX CETOSTEARYL ALCOHOL CETEARYL OLIVATE CETEARYL GLUCOSIDE CHAMOMILE CHAMOMILE FLOWER OIL COCAMIDOPROPYL BETAINE ETHYLHEXYLGLYCERIN COD LIVER OIL SUNFLOWER OIL PHENOXYETHANOL SORBITAN OLIVATE .ALPHA.-TOCOPHEROL ACETATE
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.Packaging cream203
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:
Dermal Cream for cuts & burns ACCEPTED NATIONALECZEMA.ORG NATIONAL ECZEMA ASSOCIATION PROPERTIES: CUREFINI CREAM has been specially developed for the needs of sensitive skin. Contains a delicate combination of petrolatum and fat acids of vegetal origin. Manufactured for: REV PHARMA Corp. 153 SW 22 nd Road, MIAMI, FL 33129 (1786) 574-0011 US Patent #10.016.466 B1
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, consult physician. • Do not use if tamper evident seal is broken.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? (M-F) (9-5pm EST)
Storage and handling
Information about safe storage and handling of the drug product.Other information: • Store at room temperature. • Do not use if tamper evident seal is broken.
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 • Avoid contact with eyes. • If symptoms persist for more than seven days, discontinue use and consult physician. • Keep out of reach of children. If swallowed, consult physician. • Do not use if tamper evident seal is broken.
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