Label: HEMORRHOIDAL COOLING GEL- phenylephrine and witch hazel gel

  • Category: HUMAN OTC DRUG LABEL

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 February 1, 2010

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  • ACTIVE INGREDIENT

    Phenylephrine HCI, 0.25%
    Witch Hazel, 50.0%

  • PURPOSE

    Vasoconstrictor
    Astringent

  • USES

    • Helps relieve the local itching and discomfort associated with hemorrhoids
    • Temporary relief of irritation and burning
    • Temporarily shrinks hemorrhoidal tissue
    • Aids in protecting irritated anorectal areas
  • WARNINGS

    For external use only.


    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • high blood pressure
    • 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

    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put into the rectum 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 breastfeeding,

    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.

  • DIRECTIONS

    • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a 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: ask a doctor.
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    Store at room temperature: 20° - 25° C (68° - 77° F)
  • INACTIVE INGREDIENTS

    aloe barbadensis gel, benzophenone-4, edetate disodium, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, vitamin E, water
  • QUESTIONS


  • PACKAGE INFORMATION - TUBE

    Walgreens


    FOR YOUR SAFETY, TUBE IS SEALED. DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN OR MISSING. This package has an outer carton. Do not buy if outer carton is missing.

    HEMORRHOIDAL
    Cooling Gel

    Fast Cooling Relief with Aloe

    • Clear, non-greasy formula with no unpleasant odor
    • Relief from painful burning and itching
    • Shrinks swollen hemorrhoidal tissue 
    • With vitamin E


    NET WT 0.9 OZ (26 g)


    Distributed by Walgreens Co. Deerfield, IL 60015-4616
    Made in U.S.A.

    100% Satisfaction Guaranteed
    www.walgreens.com

    tube

  • PACKAGE INFORMATION - CARTON

    Walgreens

    NDC 0363-0400-16

    Retain Carton for Complete Information

    HEMORRHOIDAL
    Cooling Gel

    Fast Cooling Relief with Aloe

    • Clear, non-greasy formula with no unpleasant odor
    • Relief from painful burning and itching
    • Shrinks swollen hemorrhoidal tissue 
    • With vitamin E

    NET WT 0.9 OZ (26 g)

    Compare to Preparation H® Cooling Gel active ingredients*

    FOR YOUR SAFETY, TUBE IS SEALED. DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN OR MISSING.

    Distributed by Walgreens Company
    Deerfield, IL 60015-4616    Made in U.S.A.

    100% Satisfaction Guaranteed    www.walgreens.com

    *This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.


    carton

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL COOLING GEL 
    phenylephrine and witch hazel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 1 g
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL50 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0400-161 in 1 BOX
    126 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/01/2006
    Labeler - Walgreen Company (008965063)
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