Label: HEMORRHOIDAL- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride and petrolatum cream 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

If you are a consumer or patient please visit this version.

  • Active ingredients

    Glycerin 14.4%

    Phenylephrine HCl 0.25%

    Pramoxine HCl 1%

    White petrolatum 15%

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  • Purpose

    Protectant

    Vasoconstrictor

    Local anesthetic

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  • 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
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  • 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.

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  • 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
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  • Other information

    store at 20°-25°C (68°-77°F)
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  • 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

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the active ingredients of Preparation H® Cream

    H E M O R R H O I D A L C R E A M

    Maximum Strength Pain Relief

    Smooth Cream Formula with Aloe

    Rapid Soothing Pain Relief From Painful Burning, Itching And Discomfort

    Shrinks Swollen Hemorrhoidal Tissue

    Protects Irritated Tissue

    Relieves External Discomfort

    Hemorrhoidal Cream Carton Image 1
    Hemorrhoidal Cream Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL 
    glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37808-944
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (GLYCERIN) GLYCERIN 14.4 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 0.25 g  in 100 g
    PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 1 g  in 100 g
    PETROLATUM (PETROLATUM) PETROLATUM 15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    BUTYLATED HYDROXYANISOLE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    CETYL ALCOHOL  
    CITRIC ACID MONOHYDRATE  
    EDETATE DISODIUM  
    GLYCERYL MONOSTEARATE  
    LAURETH-23  
    METHYLPARABEN  
    MINERAL OIL  
    PANTHENOL  
    PROPYL GALLATE  
    PROPYLPARABEN  
    WATER  
    SODIUM BENZOATE  
    STEARETH-2  
    STEARETH-20  
    STEARYL ALCOHOL  
    .ALPHA.-TOCOPHEROL  
    XANTHAN GUM  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-944-24 1 in 1 CARTON
    1 51 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 10/25/2012
    Labeler - H E B (007924756)
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