Label: GRANULOTION MEDICATED- menthol, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 29, 2024

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  • DRUG FACTS

  • Active Ingredients:

    Menthol 0.11%, Zinc Oxide 5.1%

    Purpose:

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

  • 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.

  • 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, 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.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    GRANULOTION MEDICATED 
    menthol, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82897-544
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.1 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION51 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LICORICE (UNII: 61ZBX54883)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEG-100 MONOSTEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM ALUM (UNII: 1L24V9R23S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82897-544-0014 g in 1 TUBE; Type 0: Not a Combination Product10/14/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01510/14/2024
    Labeler - GL HEALTH, INC. (086010932)