GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE, LLC]

GRANULOTION (MENTHOL, ZINC OXIDE) LOTION [PURE SOURCE, LLC]
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NDC 65121-885-23
Set ID 81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3
Category HUMAN OTC DRUG LABEL
Packager Pure Source, LLC
Generic Name
Product Class
Product Number
Application Number PART346
  • GranuLotion medicated lotion


  • Active Ingredients

    Menthol 0.11%

    Zinc Oxide 5.1%

  • Purpose

    External analgesic / Anti-itch

    Skin protectant / Anorectal astringent

  • 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.

  • 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.

  • 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 1oz/28.349g (65121-885-23)

    GranuLotionA

    GranuLotionB

  • INGREDIENTS AND APPEARANCE
    GRANULOTION 
    menthol, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-885
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.11 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.1 g  in 100 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)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM ALUM (UNII: 1L24V9R23S)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-885-231 in 1 BOX02/09/2017
    128.349 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/26/2014
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-885)

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