Simply Vital Hemorrhoid And Anorectal Relief Cream
FDA Label NDC 82460-262

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alpha Plants Inc for the product Simply Vital Hemorrhoid And Anorectal Relief (NDC 82460-262). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses:, warnings:, do not, when using this product, discontinue use and consult a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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:

Label (Label)

Label (Label)

* Please review the disclaimer below.