CVS HEMORRHOIDAL COOLING (WITCH HAZEL, PHENYLEPHRINE HYDROCHLORIDE) GEL [CVS PHARMACY]

CVS HEMORRHOIDAL COOLING (WITCH HAZEL, PHENYLEPHRINE HYDROCHLORIDE) GEL [CVS PHARMACY]
PDF | XML

NDC 59779-265-61
Set ID 11560597-3b0e-423c-a222-b20bbd98aae9
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
  • ACTIVE INGREDIENT

    Active ingredients                                        Purpose

    Phenylephrine hydrochloride 0.25%.............................Vasoconstrictor
    Witch hazel 50.0%.....................................................Astringent
  • PURPOSE


    Uses

    - temporarily relieves irritation and burning
    - helps relieve the local itching and discomfort associated with hemorrhoids
    - temporarily shrinks hemorrhoidal tissue
    - aids in protecting irritated anorectal areas
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If swallowed, get medical help or contact
    a Poison Control Center right away.
  • INDICATIONS & USAGE


    Uses

    - temporarily relieves irritation and burning
    - helps relieve the local itching and discomfort associated with hemorrhoids
    - temporarily shrinks hemorrhoidal tissue
    - aids in protecting irritated anorectal areas
     

    Other information
    - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)

  • WARNINGS

    Warnings

    For external use only.

    Ask a doctor before use if you have

    - heart disease - high blood pressure - thyroid disease - diabetes
    - trouble urinating due to an enlarged prostate gland

    Ask a doctor before use if you have
    - heart disease
    - high blood pressure
    - diabetes
    - thyroid disease
    - trouble urinating due to an enlarged 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
    - do not exceed the recommended daily dosage
    - do not put into 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

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

    Keep out of the reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION


    Directions

    - adults: when practical, cleanse and gently dry the affected area by patting or blotting with an
    appropriate cleansing tissue or soft cloth before applying gel
    - when first opening the tube, puncture foil seal with top end of cap
    - apply externally to the affected area up to 4 times daily, especially at night,
    in the morning or after each bowel movement

    - children under 12 years of age: ask a doctor


  • INACTIVE INGREDIENT

    Inactive Ingredients aloe barbadensis leaf juice, benzophenone-4, disodium EDTA,
    hydroxyethylcellulose. methyl paraben, polysorbate 80, propylene glycol, propylparaben,
    purified water, sodium citrate, tocopheryl acetate

  • PRINCIPAL DISPLAY PANEL

    c


  • INGREDIENTS AND APPEARANCE
    CVS HEMORRHOIDAL COOLING  
    witch hazel, phenylephrine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-265
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: ZYD53NBL45)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-265-611 in 1 CARTON
    151 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34611/18/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture

Related Drugs