Granulotion Medicated Lotion

Granulotion Medicated Lotion
SPL v1
SPL
SPL Set ID 01701780-b160-415b-b34d-362237179475
Route
TOPICAL
Published
Effective Date 2024-10-24
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 Monostearate Phenoxyethanol Polysorbate 20 Potassium Alum .alpha.-tocopherol Acetate Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-14

Description

Menthol 0.11%, Zinc Oxide 5.1%

Purpose

External analgesic, Anti-itch, Skin protectant, Anorectal astringent


Medication Information

Purpose

External analgesic, Anti-itch, Skin protectant, Anorectal astringent

Description

Menthol 0.11%, Zinc Oxide 5.1%

Uses:

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:

External analgesic, Anti-itch, Skin protectant, Anorectal astringent

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
Drug Facts

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.

Package Labeling:

Active Ingredients:

Menthol 0.11%, Zinc Oxide 5.1%

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Betaglucans, Cetearyl 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.


Structured Label Content

Uses: (USES:)

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:

External analgesic, Anti-itch, Skin protectant, Anorectal 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
Drug Facts (DRUG FACTS)

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.

Package Labeling:

Active Ingredients:

Menthol 0.11%, Zinc Oxide 5.1%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Betaglucans, Cetearyl 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.


Advanced Ingredient Data


Raw Label Data

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