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| Product NDC Code | 70463-000 | ||||
|---|---|---|---|---|---|
| Drug Name | Somxl |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 312881 | ||||
| Application Number | M028 | ||||
| Labeler Name | WR Group Skin Care Ltd | ||||
| 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 Salicylic acid 17% (w/w) Purpose Wart remover
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 Wash affected area (May soak wart in warm water for 15-minutes if desired). Dry area throughly. Apply small amount with applicator to cover each wart. Let dry. Repeat this procedure once ot twice daily as needed for up to 12-weeks.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients castor oil, ethyl lactate, flexible collodion, polybutene, (Contains alcohol 18% v/v and ether 53% v/v from flexible collodion.)
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 the removal of common warts. The common wart is easily recognized by the rough "cauliflower-like" appearace on the surface.
Purpose
Information about the drug product’s indications for use.Purpose Wart remover
Spl product data elements
Usually a list of ingredients in a drug product.SOMXL SALICYLIC ACID CASTOR OIL ETHYL LACTATE 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: 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
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 irritated skin on any area that is infected or reddened if you are diabetic or if you have poor blood circulation piles birthmarks warts with hair growing from them on moles warts on the face or mucous membreanes
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 discomfort persists
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.Warnings For external use only If product gets into eyes, flush with water for 15-minutes. Avoid inhaling vapors. Do not use on irritated skin on any area that is infected or reddened if you are diabetic or if you have poor blood circulation piles birthmarks warts with hair growing from them on moles warts on the face or mucous membreanes Stop use and ask a doctor if discomfort persists If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a 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