Label: RITEAID HEMORRHOIDAL COOLING- witch hazel, phenylephrine hydrochloride gel

  • 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 November 18, 2010

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  • 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. methylparaben, polysorbate 80, propylene glycol, propylparaben,
    purified water, sodium citrate, tocopheryl acetate

  • PRINCIPAL DISPLAY PANEL


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  • INGREDIENTS AND APPEARANCE
    RITEAID HEMORRHOIDAL COOLING  
    witch hazel, phenylephrine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0407
    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 AT 1%) (UNII: ZYD53NBL45)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0407-91 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 - Rite Aid Corporation (014578892)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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