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Product NDC Code | 59434-134 | ||||
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Drug Name | Ala-septic |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
RxCUI drug identifier | 103568 | ||||
Application Number | M032 | ||||
Labeler Name | Ala-Septic Pharmaceutical Research LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Salicylic Acid 2.00% Purpose Seborrheic Dermatitis, Psoriasis
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 to affected areas one to four times daily or as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzoic Acid, Butylene Glycol, C13-14 Isoparaffin, Ethylhexylglycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Iodoquinol, Isopropyl Myristate, Larrea Tridentata Extract, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Phenoxyethanol, Polyacrylamide, Polysorbate-20, SD-Alcohol 40B, 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.Use For: For relief of the symptoms of seborrheic dermatitis and psoriasis.
Purpose
Information about the drug product’s indications for use.Purpose Seborrheic Dermatitis, Psoriasis
Spl product data elements
Usually a list of ingredients in a drug product.ALA-SEPTIC SALICYLIC ACID ALOE VERA LEAF WATER BENZOIC ACID BUTYLENE GLYCOL C13-14 ISOPARAFFIN ETHYLHEXYLGLYCERIN GLYCYRRHIZA GLABRA IODOQUINOL ISOPROPYL MYRISTATE LARREA TRIDENTATA LEAF LAURETH-7 MELALEUCA ALTERNIFOLIA LEAF PHENOXYETHANOL POLYSORBATE 20 .ALPHA.-TOCOPHEROL ACETATE SALICYLIC ACID SALICYLIC ACID
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: Bottle Label
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 before using this product if 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 a Poison Control Center right away.
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 as directed.
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.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health 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.Warning: For external use only. When using this product Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. Ask a doctor before using this product if condition covers a large area of the body Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use
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