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| Product NDC Code | 68726-680 | ||||
|---|---|---|---|---|---|
| Drug Name | Pca skin skin procedure |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| RxCUI drug identifier | 2467180 | ||||
| Application Number | M016 | ||||
| Labeler Name | CP Skin Health Group, Inc. | ||||
| 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 ingredient Petrolatum 60% Purpose Skin protectant (ointment)
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 or as directed by physician for best results, apply liberally to moist skin.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamus Tincotirius (Safflower) Seed Oil, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Panthenol, Phenoxyethanol, Rosamarinus Officinalis (Rosemary) Leaf Extract, Silybum Marianum Fruit Extract, Stearyl Glycyrrhetinate, Tocopherol, Tocopheryl Acetate.
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: º cuts º scrapes º burns • helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin • helps prevent and protect skin from the drying effects of wind and cold weather
Purpose
Information about the drug product’s indications for use.Purpose Skin protectant (ointment)
Spl product data elements
Usually a list of ingredients in a drug product.PCA Skin Skin Procedure PETROLATUM SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES SAFFLOWER OIL HELIANTHUS ANNUUS FLOWERING TOP HELIANTHUS ANNUUS SEED WAX RICE BRAN PANTHENOL PHENOXYETHANOL ROSEMARY MILK THISTLE STEARYL GLYCYRRHETINATE TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE 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.Package Labeling: Label0
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 Do not use if package is broken or open protect this product from excessive heat and direct sun noncomedogenic fragrance-free hypoallergenic
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 on deep or puncture wounds animal bites serious burns Do not use on damaged and broken skin
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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Please call 877.722.7546
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
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
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 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 Do not use on deep or puncture wounds animal bites serious burns Do not use on damaged and broken skin Keep out of reach of children
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