Label: HEMOTREAT- camphor suppository

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 2, 2020

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  • Drug Facts


  • Active Ingredients

    DL-CAMPHOR (2.5%) wt/wt

  • Purposes

    Analgesic

  • Uses

    • Helps relieve itching and discomfort associated with hemorrhoids and anorectal disorders
    • Temporarily relieves pain associated with anorectal inflammation and inflamed hemorrhoidal tissues
    • May provide cooling sensation
  • Warnings

    For rectal use only

  • DO NOT USE

    Do not use for more than 30 consecutive days

    When using this product do not exceed the recommended daily dosage, unless directed by a doctor

  • Stop use and ask a doctor if:

    • Bleeding occurs
    • Condition worsens or does not improve within seven days
    • Signs of a local infection appear
    • Certain person can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside of if redness, irritation, swelling, pain, and or other symptoms develop or increase, discontinue use and consult a doctor.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed, get medical help or contact a poison Control Center right away 1 (800) 222-1222.

    Children under 12 years: consult a doctor

  • Directions

    Adults

    • When practical, cleanse the affected area with mild soap and warm water
    • Gently dry by patting or blotting with toilet tissue or a soft cloth before insertion of this product.
    • Detach one suppository from the strip, remove the foil wrapper before inserting into the rectum as follows:
      • Hold suppository with rounded end up
      • Carefully separate foil tabs by inserting tip of fingernail at the end
      • Slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides to expose the suppository
      • Remove exposed suppository from wrapper
      • Insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
  • Other Information

    • Store at 15-25°C (59-77°F)
    • Protect from excessive moisture
    • Keep away from direct sunlight
  • Inactive Ingredients

    Aloe Vera Leaf Extract, Calendula Officinalis Extract, Achillea Millefolium Extract, Ethanol, Clove Oil, Witepsol H15, Phenoxyethanol, Ethylhexylglycerin, BHA

  • QUESTIONS

    Manufactured by SC Global Treat SRL

    157 Portului Street, 800211, Galati, Romania

    Web: www.hemotreat.com

    EMail: contact@hemotreat.com

    Questions? Call: 1 (800) 580-2238

  • Principal Display Panel

    NDC 69758-328-88

    HemoTreat

    Hemorrhoidal Suppositories

    Product Label

  • INGREDIENTS AND APPEARANCE
    HEMOTREAT 
    camphor suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69758-328
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ACHILLEA MILLEFOLIUM OIL (UNII: 97P5D0WG43)  
    ALCOHOL (UNII: 3K9958V90M)  
    CLOVE OIL (UNII: 578389D6D0)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69758-328-8812 in 1 CARTON10/31/2016
    13 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34610/31/2016
    Labeler - Global Treat srl (505948710)
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