FDA Label for Simply Vital Hemorrhoid And Anorectal Relief

View Indications, Usage & Precautions

Simply Vital Hemorrhoid And Anorectal Relief Product Label

The following document was submitted to the FDA by the labeler of this product Alpha Plants Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Lidocaine 5.00 %


Purpose



Anorectal (hemorrhoidal)


Uses:



  • For the temporary relief of itching and discomfort in the perianal area.
  • For the temporary relief of pain, soreness, or burning.

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.
  • Allergy alert

    • Certain persions can develop allergic reactions to ingredients in this product.

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.


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.


Other Information:



  • Store at 20-25°C (68-77°F) and protect from moisture.

Inactive Ingredients:



Allantoin, Deionized Water, Benzyl Alcohol, Carbomer, Propylene Glycol, SD Alcohol 40-B, Sodium Polyacrylate, Tocopheryl Acetate (Vitamin E).


Questions?



+1 (205) 624-9177


Package Labeling:




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