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  5. Label Information: Granulotion Hemorrhoidal

FDA Label for Granulotion Hemorrhoidal

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. INACTIVE INGREDIENTS
    9. PACKAGE LABELING:

Granulotion Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Gl Health, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


Package Labeling:



Label - Label

Label - Label


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