Granulotion Medicated Lotion

Granulotion Medicated Lotion
SPL v4
SPL
SPL Set ID 81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3
Route
TOPICAL
Published
Effective Date 2014-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.11 g) Zinc Cation (5.1 g)
Inactive Ingredients
Tea Tree Oil Olive Oil Peg-100 Stearate Phenoxyethanol Polysorbate 20 Potassium Alum .alpha.-tocopherol Fd&c Blue No. 1 Aloe Vera Leaf Water Cetostearyl Alcohol Ethylhexylglycerin Glycerin Glyceryl Monostearate Licorice Sunflower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-26

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 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.

Section 50565-1



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.

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.

Granulotion Medicated Lotion



Granulotion Medicated Lotion 1oz/28.349g (65121 885 23)





Structured Label Content

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.

Section 50565-1 (50565-1)



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.

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.

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.

Granulotion Medicated Lotion (GranuLotion medicated lotion)



Granulotion Medicated Lotion 1oz/28.349g (65121 885 23) (GranuLotion medicated lotion 1oz/28.349g (65121-885-23))





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