Label: CALMOL 4- zinc oxide and cocoa butter suppository

  • NDC Code(s): 67492-104-11, 67492-104-12, 67492-104-13
  • Packager: Resical Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 12, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients (in each suppository)

    Cocoa Butter 76%

    Zinc Oxide 10%

  • Purpose

    Protectant

    Astringent

  • Uses

    • gives temporary relief of burning, irritation, itching and discomfort associated with hemorrhoids
    • temporarily provides a coating for for anorectal discomforts
    • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

  • Warnings

    For rectal use only

    When using this product

    do not exceed the recommended daily dosage unless directed by a doctor

    Stop use and ask doctor if

    bleeding occurs or if condition worsens or does not improve within 7 days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad
    • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
    • detach one suppository from the strip; remove wrapper before inserting into rectum as follows:
      • slowly peel down film wrapper by pulling evenly and slowly on tabs to expose suppository
    • insert 1 suppository bulb shape first into the rectum up to 6 times daily or after each bowl movement
    • children under 12 years of age, consult a doctor

  • Other information

    • store in a cool place not ober 80°F to avoid melting
    • if subjected to higher temperatures, refrigeration may restore to a usable condition

  • Inactive ingredients

    Bismuth subgallate, glyceryl stearate, hydrogenated vegetable oil, methylparaben, propylparaben

  • Questions or comments?

    Call toll-free 1-800-204-6434 weekdays 9 AM to 5 PM EST

  • Calmol 4 Suppository 24 count

    Calmol 4 Hemorrhoidal Suppository

    24 count

    Distributed by: Resical Inc.

    Orchard Park, New York 14127

    The image below depicts a representative sample of packaging that is available.

    Calmol Suppository 24ct

  • INGREDIENTS AND APPEARANCE
    CALMOL 4 
    zinc oxide and cocoa butter suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67492-104
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE270 mg
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER2052 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FAT, HARD (UNII: 8334LX7S21)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BISMUTH SUBGALLATE (UNII: YIW503MI7V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67492-104-114 in 1 CARTON05/13/2006
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:67492-104-122 in 1 CARTON05/13/2006
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:67492-104-131 in 1 CARTON05/13/2006
    32 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01505/13/2006
    Labeler - Resical Inc. (927081369)
    Registrant - DSC Laboratories Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories Inc.097807374manufacture(67492-104)