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Calmol 4 (Resical Inc.)

Available Formats

Dosage Form Package Information Links
SUPPOSITORY 1 BLISTER PACK in 1 CARTON (67492-104-13) > 2 SUPPOSITORY in 1 BLISTER PACK Label Information
SUPPOSITORY 2 BLISTER PACK in 1 CARTON (67492-104-12) > 6 SUPPOSITORY in 1 BLISTER PACK Label Information
SUPPOSITORY 4 BLISTER PACK in 1 CARTON (67492-104-11) > 6 SUPPOSITORY in 1 BLISTER PACK Label Information

Complete Calmol 4 Information

  • 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 represeentative sample of packaging that is available.

    Calmol 4 Suppository 24


  • INGREDIENTS AND APPEARANCE
    CALMOL 4 
    zinc oxide and cocoa butter suppository
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67492-104
    Route of Administration RECTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 270 mg
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 2052 mg
    Inactive Ingredients
    Ingredient Name Strength
    BISMUTH SUBGALLATE (UNII: YIW503MI7V)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    FAT, HARD (UNII: 8334LX7S21)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67492-104-11 4 in 1 CARTON 05/13/2006
    1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:67492-104-12 2 in 1 CARTON 05/13/2006
    2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:67492-104-13 1 in 1 CARTON 05/13/2006
    3 2 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 05/13/2006
    Labeler - Resical Inc. (927081369)
    Registrant - DSC Laboratories, Div. of DSC Products Inc. (097807374)
    Establishment
    Name Address ID/FEI Business Operations
    DSC Laboratories, Div. of DSC Products Inc. 097807374 manufacture(67492-104)