Label: RECTIBIOM HEMORRHOID RELIEF- rectibiom suppositories suppository

  • NDC Code(s): 72959-005-01
  • Packager: Biom Pharmaceutical Corporation
  • 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 February 20, 2023

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  • ACTIVE INGREDIENTS


    Phenylephrine HCI, 0.25%

    Hard Fat, 88.44%

  • PURPOSE

    protectant

    vasoconstrictor

    protectant

  • USES

    • Helps relieve the local itching and discomfort associated with hemorrhoids
    • Temporarily relieves burning and shrinks hemorrhoidal tissue.
    • Temporarily provide a coating for relief of anorectal discomforts.
    • Temporarily protects the inflammed, irritated anorectal surface to  help make bowel movements less painful.
  • WARNINGS

    For rectal use only.


    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland
    • high blood pressure
    • diabetes

    Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug for high blood pressure or depression.

    When using this product

    do not exceed the recommended daily dosage.

    Stop use and ask a doctor if

    • you experience bleeding
    • condition worsens or does not improve within 7 days.

    These may be signs of a serious condition.

    If pregnant or breastfeeding

     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 tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before insertion of this product.
    • Detach one suppository from strip
    • Remove wrapper before inserting into rectum
    • Hold suppository with rounded end up and insert tip of fingernail at end marked "peel down"
    • Carefully peel film slowly and evenly down both sides to expose suppository
    • Insert one suppository into rectum up to 4 times daily especially at night and morning or after each bowel movement

    Children under 12 years:  ask a doctor

  • STORAGE

    Store  at 20-250C(68-770C)

  • INACTIVE INGREDIENTS

    Silica gel, Hyaluronic acid, olive oil, Shea Butter, sesame seed oil, Probiotics(Lactobacillus reuteri, Lactobacillus Rhamnosus)

  • QUESTIONS

    Call Weekdays 9 AM to 5PM est at +1941-552-8417

  • BOX INFORMATION - 15 count

    image description

  • INGREDIENTS AND APPEARANCE
    RECTIBIOM HEMORRHOID RELIEF 
    rectibiom suppositories suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72959-005
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride0.25 g
    HARD FAT (UNII: 8334LX7S21) (FAT, HARD - UNII:8334LX7S21) HARD FAT88.44 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SESAME OIL (UNII: QX10HYY4QV)  
    LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    LACTICASEIBACILLUS RHAMNOSUS (UNII: 9601IVB87J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72959-005-0115 in 1 BOX; Type 1: Convenience Kit of Co-Package03/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/15/2023
    Labeler - Biom Pharmaceutical Corporation (080828422)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biom Pharmaceutical Corporation080828422manufacture(72959-005)
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