Granulotion Hemorrhoidal Lotion

Granulotion Hemorrhoidal Lotion
SPL v3
SPL
SPL Set ID 1a32741c-5e4a-40e5-b15a-8233c5bdb92b
Route
TOPICAL
Published
Effective Date 2022-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.1 mg) Zinc Cation (51 mg)
Inactive Ingredients
Aloe Vera Leaf Water Cetostearyl Alcohol Ethylhexylglycerin Glycerin Glyceryl Monostearate Licorice Helianthus Annuus Flowering Top Tea Tree Oil Olive Oil Peg-100 Stearate Phenoxyethanol Polysorbate 20 Potassium Alum .alpha.-tocopherol Acetate Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-20

Description

Menthol 0.11% Zinc Oxide 5.1%

Purpose

Analgesic, Anesthetic and Antipruritic Astringent


Medication Information

Purpose

Analgesic, Anesthetic and Antipruritic

Astringent

Description

Menthol 0.11% Zinc Oxide 5.1%

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
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.

Drug Facts

Package Labeling:

Active Ingredients

Menthol 0.11%

Zinc Oxide 5.1%

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.

Keep Out of Reach of Children.


Structured Label Content

Use (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.

Purpose (PURPOSE)

Analgesic, Anesthetic and Antipruritic

Astringent

Warnings (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
Directions (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.

Drug Facts (DRUG FACTS)

Package Labeling:

Active Ingredients (ACTIVE INGREDIENTS)

Menthol 0.11%

Zinc Oxide 5.1%

Inactive Ingredients (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.

Keep Out of Reach of Children. (Keep out of reach of children.)


Advanced Ingredient Data


Raw Label Data

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