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Product NDC Code | 54323-103 | ||||||
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Drug Name | Flanders healing |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | OINTMENT | ||||||
RxCUI drug identifier | 2539434 | ||||||
Application Number | M016 | ||||||
Labeler Name | Flanders Inc | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient White Petrolatum(40%)
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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aloe extract, Beeswax, Helianthus Annus (sunflower oil), Olea Europea (olive oil), 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: Temporarily protects minor: Cuts, scrapes and burns Temporarily protects chapped or cracked skin. Helps protect from the drying effects of wind and cold weather.
Purpose
Information about the drug product’s indications for use.Skin Protectant
Spl product data elements
Usually a list of ingredients in a drug product.Flanders Healing White Petrolatum PETROLATUM PETROLATUM OLIVE OIL ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE SUNFLOWER OIL PEG-8 BEESWAX Slightly yellow to clear
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.Tube Image Tube Image
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.*Do not use if tamper seal is broken or missing
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 855-649-7274
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 and ask a doctor if: Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding Ask a health care professional before use.
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.FOR EXTERNAL USE ONLY
Do not use on Deep or puncture wounds animal bites serious burns
When using this product: Do not get into eyes
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