Granulotion Hemorrhoidal Lotion
FDA Label NDC 82897-293

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gl Health, Inc. for the product Granulotion Hemorrhoidal (NDC 82897-293). 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, use, warnings, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Menthol 0.11%

Zinc Oxide 5.1%

Purpose

Analgesic, Anesthetic and Antipruritic

Astringent

Use

Helps relieve local itching and discomfort of the perianal area. Temporarily forms a protective barrier over inflamed tissues to help prevent drying of tissues. For the temporary relief of pain, burning and skin irritation. Can help distract the pain and may provide cooling sensation.

Warnings

For external use only

  • If condition worsens or does not improve within 7 days, consult a doctor
  • Do not exceed the recommended daily dose unless directed by a doctor
  • In case of bleeding, consult a doctor promptly
  • Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor

Keep Out Of Reach Of Children.

Directions

When practical, cleanse the affected area with mild soap and warm water. Pat or allow to air dry. Apply a layer of GranuLotion® up to 6 times daily for inflammation, 1 time per day for continued site maintenance. Use a soft tipped applicator for hard to reach areas. Repeat as needed to protect the skin or until the condition resolves.

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Betaglucans, Cetearly Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycrrhiza Glabra (Licorice Extract, Helianthus Annuus (Sunflower) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Olea Europaea (Olive) Oil, PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Potassium Alum, Tocopheryl Acetate (Vitamin E), FDandC Blue 1.

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