Label: GRANULOTION - menthol and zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/14

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  • GranuLotion medicated lotion
  • Active Ingredients

    Menthol 0.11%

    Zinc Oxide 5.1%

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  • Purpose

    External analgesic / Anti-itch

    Skin protectant / Anorectal astringent

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  • 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.

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  • 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.


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  • 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.

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  • 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.

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  • GranuLotion medicated lotion 1oz/28.349g (65121-885-23)
  • INGREDIENTS AND APPEARANCE
    GRANULOTION 
    menthol, zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65121-885
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 0.11 g  in 100 g
    ZINC OXIDE (ZINC CATION) ZINC CATION 5.1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    WATER  
    CETOSTEARYL ALCOHOL  
    ETHYLHEXYLGLYCERIN  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    LICORICE  
    SUNFLOWER OIL  
    TEA TREE OIL  
    OLIVE OIL  
    PEG-100 STEARATE  
    PHENOXYETHANOL  
    POLYSORBATE 20  
    POTASSIUM ALUM  
    .ALPHA.-TOCOPHEROL  
    FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65121-885-23 1 in 1 BOX
    1 28.349 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 03/26/2014
    Labeler - Pure Source Inc (969241041)
    Establishment
    Name Address ID/FEI Business Operations
    Pure Source Inc 969241041 manufacture(65121-885)
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