Label: REXALL HEMORRHOIDAL COOLING GEL- witch hazel and phenylephrine hydrochloride cream

  • 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 6, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Hamamelis virginiana (witch hazel) 50%Astringent
    Phenylephrine hydrochloride 0.25%Vasoconstrictor
  • Uses

    • temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders
    • temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders
    • temporarily shrinks hemorrhoidal tissue
    • aids in protecting irritated anorectal areas
    • temporary relief of burning
  • Warnings

    For external use only.

    Do not use this product

    • if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

    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 recommended daily dosage unless directed by a doctor
    • do not put into rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

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

    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: 800-222-1222.

  • Directions

    • Adults
      • when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel
      • apply externally to affected area up to 4 times daily or after each bowel movement
    • Children under 12 years old: Ask a doctor.
  • Other information

    • Store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
  • Inactive ingredients

    aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, phenoxy ethenol, propylene glycol, purified water, sodium benzoate, sodium citrate

  • PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

    NDC 55910-332-24

    Since 1903
    Rexall®

    CLEAR, NON-GREASY FORMULA

    Hemorrhoidal Cooling Gel

    Enriched
    with
    Aloe

    • Prompt cooling relief from painful burning & itching
    • Relieves external discomfort

    NET WT 0.9 OZ (26 g)

    PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    REXALL HEMORRHOIDAL COOLING GEL 
    witch hazel and phenylephrine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34) Witch Hazel0.5 mg  in 1 g
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride0.0025 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Benzophenone (UNII: 701M4TTV9O)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Hydroxyethyl Cellulose (280 Mpa.S At 2%) (UNII: 12VCE9HR9E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Anhydrous Trisodium Citrate (UNII: RS7A450LGA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-332-241 in 1 CARTON03/18/2014
    126 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Finalpart34603/18/2014
    Labeler - DOLGENCORP, LLC (068331990)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(55910-332)
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