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| Product NDC Code | 82460-262 | ||||
|---|---|---|---|---|---|
| Drug Name | Simply vital hemorrhoid and anorectal relief |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1366789 | ||||
| Application Number | M015 | ||||
| Labeler Name | ALPHA PLANTS 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 Lidocaine 5.00 % Purpose Anorectal (hemorrhoidal)
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: Adults:• When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. • Children under 12 years of age: consult a doctor. • Apply to the affected area up to 6 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Allantoin, Deionized Water, Benzyl Alcohol, Carbomer, Propylene Glycol, SD Alcohol 40-B, Sodium Polyacrylate, 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.Uses: For the temporary relief of itching and discomfort in the perianal area. For the temporary relief of pain, soreness, or burning.
Purpose
Information about the drug product’s indications for use.Purpose Anorectal (hemorrhoidal)
Spl product data elements
Usually a list of ingredients in a drug product.SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF LIDOCAINE ALLANTOIN WATER BENZYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE LIDOCAINE LIDOCAINE
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
Other information: Store at 20-25°C (68-77°F) and protect from moisture.
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.Discontinue use and consult a doctor if The symptoms being treated does not subside. Redness, irritation, swelling, pain, or other symptoms develop or increase. Certain persions can develop allergic reactions to ingredients in this product. Allergy alert
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 Put this product into the rectum by using fingers or any mechanical device or applicator. Exceed the recommended daily dosage unless directed by a doctor.
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. get medical help or contact a Poison Control Center right away. If swallowed,
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? +1 (205) 624-9177
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 If condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult a doctor promptly.
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. Do not Put this product into the rectum by using fingers or any mechanical device or applicator. Exceed the recommended daily dosage unless directed by a doctor. When using this product If condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult a doctor promptly. Discontinue use and consult a doctor if The symptoms being treated does not subside. Redness, irritation, swelling, pain, or other symptoms develop or increase. Certain persions can develop allergic reactions to ingredients in this product. Allergy alert Keep out of reach of children. get medical help or contact a Poison Control Center right away. If swallowed, 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