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Product NDC Code | 65121-712 | ||||||
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Drug Name | Curefini |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | OINTMENT | ||||||
RxCUI drug identifier | 1440007 | ||||||
Application Number | M016 | ||||||
Labeler Name | Pure Source, LLC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients: Petrolatum 30.00% Cod Liver Oil 10.00 % Purpose: Skin Protectant
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 as needed. Prepare a gauze bandage to apply. Dressing should be placed on a clean and flat surface. Apply ointment with a spatula, covering the entire surface with a thin layer. Place bandage directly on top of affected area. Make sure affected area remains covered by ointment.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Beeswax, BHT, Chamomilla Recutita (Chamomile) Oil, Helianthus Annuus (Sunflower) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil.
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 minor cuts, scrapes and burns. Temporarily protects chapped or cracked skin. Helps protect from 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, cod liver YELLOW WAX BUTYLATED HYDROXYTOLUENE SUNFLOWER OIL ALMOND OIL PETROLATUM PETROLATUM COD LIVER OIL COD LIVER OIL
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.Package Labeling: Curefini 120 Curefini
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:
Other information: Store at room temperature.
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 IF TAMPER EVIDENT SEAL IS BROKEN.
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, contact physician or poison control center immediately.
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. If condition worsens or does not improve for seven days, discontinue use and consult a physician.
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. If condition worsens or does not improve for seven days, discontinue use and consult a physician. DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN. Keep out of reach of children. If swallowed, contact physician or poison control center immediately.
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