SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF

SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF is an FDA drug label for the active ingredient LIDOCAINE manufactured by ALPHA PLANTS INC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231111.

Generic: LIDOCAINE

Manufacturer: ALPHA PLANTS INC

Product Type: HUMAN OTC DRUG

Route: TOPICAL

Dosage Form:

NDC: 82460-262

Application: M015

Effective: 20231111

Active Ingredients: Active ingredient Lidocaine 5.00 % Purpose Anorectal (hemorrhoidal)

Indications & Usage

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

Dosage & Administration

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.

Contraindications

Not available.

Warnings

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.

Adverse Reactions

Not available.

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