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Product NDC Code | 68726-800 | ||||
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Drug Name | Dry skin relief bar |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SOAP | ||||
RxCUI drug identifier | 2533925 | ||||
Application Number | part358H | ||||
Labeler Name | CP Skin Health Group, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid 3%
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 use on affected areas in place of your regular soap for best results use at least twice a week or as directed by a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Glycerin, Sodium Cocoate, Sodium Palm Kernelate, Sodium Castorate, Water, Sodium Safflowerate, Sorbitan Oleate, Sorbitol, Glycine Soja (Soybean) Protein, Evernia Prunastri (Oakmoss) Extract, Foeniculum Vulgare (Fennel) Oil, Lavandula Angustifolia (Lavender) Oil, Hamamelis Virginiana (Witch Hazel) Water, Lecithin, Aloe Barbadensis Leaf Juice Powder, Honey, Cucurbita Pepo (Pumpkin) Seed Oil, Phenylethyl Resorcinol, Camellia Sinensis (Black Tea) Leaf Extract, Tocopherol, Alcohol, Glycine Soja (Soybean) 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 controls and fights the recurrence of skin itching, redness, flaking and irritation associated with psoriasis and seborrheic dermatitis
Purpose
Information about the drug product’s indications for use.Purpose Psoriasis and seborrheic dermatitis treatment
Spl product data elements
Usually a list of ingredients in a drug product.Dry Skin Relief Bar Salicylic Acid SALICYLIC ACID SALICYLIC ACID GLYCERIN SODIUM COCOATE SODIUM PALM KERNELATE SODIUM CASTORATE WATER SODIUM SAFFLOWERATE SORBITAN MONOOLEATE SORBITOL SODIUM HYDROXIDE FENNEL OIL LECITHIN, SOYBEAN LAVENDER OIL HAMAMELIS VIRGINIANA TOP WATER ALOE VERA LEAF TEA LEAF PUMPKIN SEED OIL HONEY PHENYLETHYL RESORCINOL SOY PROTEIN ALCOHOL TOCOPHEROL EVERNIA PRUNASTRI SOYBEAN OIL Dark Amber Brown
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 - 90 g Jar Box PCA skin ® dry skin relief bar salicylic acid psoriasis and seborrheic dermatitis cleanser 01 | cleanse 3.2 oz (90 g) PRINCIPAL DISPLAY PANEL - 90 g Jar Box
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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor if the condition covers a large area of the body.
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.
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 or does not improve after regular use of this product.
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 avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature
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 avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product. Ask a doctor if the condition covers a large area of the body. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
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