Flarestop Hemorrhoid Lidocaine Cream
FDA Label NDC 87989-013

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chelsea Pharmacceuticals Llc for the product Flarestop Hemorrhoid Lidocaine (NDC 87989-013). 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 drug facts, active ingredients, purpose, uses, warnings, do not, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Lidocaine 5.00 %

Purpose

Local Anesthetic (anorectal)

Uses

  • Helps relieve the local itching and discomfort in the perianal area.
  • For the temporary relief of pain, irritation or burning.

Warnings

For external use only

Do Not

  • Exceed the recommended daily dosage unless directed by a doctor.
  • put this product into the rectum by using your fingers or any mechanical device or applicator.

When Using This Product

  • If the condition worsens or does not improve within 7 days, consult a doctor.
  • In case of bleeding, consult a doctor promptly.

Stop Use And Ask A Doctor If

  • If the symptoms being treated do not subside or if redness,
  • irritation, swelling, pain, or other symptoms develop or increase.

    • Allergy alert

    • Certain persons 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 by patting or blotting with an appropriate cleansing pad.
  • 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 externally to the affected area up to 6 times daily.

Other Information

  • Protect from excessive heat and direct sun. Store at 20-25°C (68°-77°F)

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Bisabolol, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Dimethicone, Ethoxydiglycol, Glycerin, Glyceryl Stearate Citrate, Glycyrrhiza Glabra (Licorice) Root Extract, 1,2-Hexanediol, Isopropyl Myristate, Panthenol, Pentylene Glycol, Polyacrylate Crosspolymer-6, Sodium Hyaluronate, Sodium Phytate, Tocopheryl Acetate, Water (Aqua).

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