Label: CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL- phenylephrine hydrochloride and witch hazel gel

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated November 18, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    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 PUNCTURED OR MISSING.
  • Inactive ingredients

    aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

  • QUESTIONS

    Questions or comments?

    866-323-0107

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    CVS Pharmacy, Inc.
    One CVS Drive
    Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

    CVS
    Health®

    Compare to the active
    ingredients in Preparation H®
    Cooling Gel*

    NDC 69842-843-01

    Hemorrhoidal
    Cooling Gel

    FAST COOLING RELIEF

    • Clear, non-greasy formula
      with soothing aloe & a
      pleasant scent
    • Shrinks swollen
      hemorrhoidal tissue
    • Prompt cooling relief from
      painful burning & itching
    • Relieves external discomfort

    Package Contains
    One Tube

    NET WT 0.9 OZ (26 g)

    PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH HEMORRHOIDAL COOLING   HEMORRHOIDAL
    phenylephrine hydrochloride and witch hazel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-843
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-843-011 in 1 CARTON11/15/2006
    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 finalpart34601/01/2004
    Labeler - CVS (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(69842-843)
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