Label: RRHOID RAGE HEMORRHOIDAL- lidocaine, phenylephrine hydrochloride ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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  • Drug Facts

  • Active Ingredients

    Lidocaine 4%

    Phenylephrine HCL 0.25%

    Purpose

    Local Anesthetic

    Vasoconstrictor

  • Uses

    –Helps relieve the pain, itching, and burning associated with hemorrhoids.

    –Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

    –Temporarily provides a coating for relief of anorectal discomforts.

    –Temporarily protects irritated areas and inflamed perianal skin.

  • Warnings

    For external use only.

    Ask a doctor before use if you have:

    –Heart disease; high blood pressure; thyroid disease; diabetes.

    –Difficulty in urination due to enlargement of the prostate gland.

    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

    –Avoid contact with eyes.

    –Do not exceed recommended daily dosage unless directed by a doctor.

    –Do not put this product into the rectum by using fingers or any mechanical device or applicator.

    Stop use and ask a doctor if

    –Bleeding occurs.

    –Condition worsens or does not improve within 7 days.

    –Allergic reaction occurs to ingredients in this product.

    –Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

    If pregnant or breastfeeding,

    ask a doctor before use.

    Keep out of reach of children.

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

  • Directions

    –When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.

    –Adults and children 12 years and older: apply externally to the affected area up to 4 times daily.

    –Children under 12 years of age: consult a doctor.

  • Other information

    –Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).

  • Inactive ingredients

    aloe extract AQ, balsam fir, butylated hydroxyanisol, glycerin, lanolin alcohols, lanolin USP, magnesium sulfate, methyl paraben, mineral oil, petrolatum, propylparaben, witch hazel, white bees wax.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    RRHOID RAGE HEMORRHOIDAL 
    lidocaine, phenylephrine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82433-446
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82433-446-001 in 1 BOX02/12/2024
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01502/12/2024
    Labeler - POPPY COLLECTIVE LLC (035330878)
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