Granulotion
FDA Label NDC 65121-885
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pure Source, Llc for the product Granulotion (NDC 65121-885). 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 granulotion medicated lotion, active ingredients, purpose, uses:, warnings, otc - 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
Active Ingredients
Menthol 0.11%
Zinc Oxide 5.1%
Purpose
External analgesic / Anti-itch
Skin protectant / Anorectal astringent
Uses:
Helps relieve the local itching and discomfort of the perianal area. Temporarily forms a protective barrier over inflamed tissues to help prevent the drying of tissues. For the temporary relief of pain, burning and skin irritation. Can help distract from pain and may provide a 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.
Otc - 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.
* Please review the disclaimer below.
