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| Product NDC Code | 65517-2020 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Dawnmist petroleum |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | JELLY | ||||||
| RxCUI drug identifier | 204754 | ||||||
| Application Number | M016 | ||||||
| Labeler Name | Dukal LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Petrolatum 100%
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 often as necessary. Principal Display Panel - Tube Label NDC 65517-2020-1 DawnMist ® INCONTINENCE Petroleum Jelly MOISTURIZES DRY CHAPPED SKIN COMPARE TO ACTIVE INGREDIENTS OF VASELINE ® 2 oz. (56 g) Principal Display Panel - Tube Label
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.Use: Temporarily protects minor cuts, scrapes and burns. Temporarily protects and helps relieve chapped or cracked skin and lips. Helps protect from the drying effect 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.Dawnmist Petroleum Petrolatum PETROLATUM PETROLATUM
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.Principal Display Panel - Tube Label NDC 65517-2020-1 DawnMist ® INCONTINENCE Petroleum Jelly MOISTURIZES DRY CHAPPED SKIN COMPARE TO ACTIVE INGREDIENTS OF VASELINE ® 2 oz. (56 g) Principal Display Panel - Tube Label
Principal Display Panel - 1oz Tube Label NDC 65517-2020-5 DawnMist ® INCONTINENCE Petroleum Jelly MOISTURIZES DRY CHAPPED SKIN 1 oz. (28 g) 1oz
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Removed information from the directions section that is not applicable to the directions.
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 Poison Control Center right away. If redness or swelling develops consult a physician promptly.
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 conditions does not improve or lasts more than 7 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. Do not use on: deep and puncture wounds lacerations or infections serious burns animal bites. Stop use and ask a doctor if conditions does not improve or lasts more than 7 days. Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away. If redness or swelling develops consult a physician promptly.
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