PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WALGREEN COMPANY]

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PAIN RELIEF (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [WALGREEN COMPANY]
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NDC 0363-5019-24
Set ID 7fec7b38-ddf5-4d84-902d-e42c0d01102b
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART346
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  • Active ingredients

    Glycerin 14.4%

    Phenylephrine HCl 0.25%

    Pramoxine HCl 1%

    White petrolatum 15%

  • Purpose

    Protectant

    Vasoconstrictor

    Local anesthetic

  • Uses

    •
    for temporary relief of pain, soreness and burning
    •
    helps relieve the local itching and discomfort associated with hemorrhoids
    •
    temporarily shrinks hemorrhoidal tissue
    •
    temporarily provides a coating for relief of anorectal discomforts
    •
    temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • 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 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 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
    •
    an allergic reaction develops
    •
    the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

    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.

  • 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 cream.
    •
    when first opening the tube, puncture foil seal with top end of cap
    •
    apply externally or in the lower portion of the anal canal only
    •
    apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    •
    for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
    •
    thoroughly cleanse dispensing cap after each use and replace cover
    •
    children under 12 years of age: ask a doctor
  • Other information

    •
    store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    aloe barbadensis leaf extract, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, vitamin E, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    VALUE SIZE

    HEMORRHOIDAL

    Pain Relief Cream

    Compare to Preparation H® Cream active ingredients

    MAXIMUM STRENGTH

    + ALOE & VITAMIN E

    CREAM

    Rapid, soothing relief from painful burning, itching & discomfort

    Shrinks swollen hemorrhoidal tissue ● Protects irritated tissue

    NET WT 1.8 OZ (51 g)

    pain-relief-cream-image
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF 
    glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN14.4 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-23 (UNII: N72LMW566G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5019-241 in 1 CARTON06/21/201811/30/2021
    151 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34606/21/201811/30/2021
    Labeler - Walgreen Company (008965063)
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