Label: HEMORRHOIDAL CREAM- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum cream

  • 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 February 15, 2023

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  • Active ingredients

    Glycerin 14.4%

    Phenylephrine HCl 0.25%

    Pramoxine HCl 1%

    White petrolatum 15%

  • Purpose

    Protectant

    Vasoconstrictor

    Local anesthetic

    Protectant

  • Uses

    • for temporary relief of pain, soreness and burning
    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily provides a coating for relief of anorectal discomforts
    • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
    • temporarily shrinks hemorrhoidal tissue
  • Warnings

    For external use only.

    When using this product

    • do not put this product into the rectum by using fingers or any mechanical device or applicator
    • do not exceed recommended daily dosage unless directed by a doctor

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty 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.

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve within 7 days
    • the symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. Some people can develop allergic reactions to ingredients in this product.

    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 (1-800-222-1222) right away.

  • Directions

    Adults:

    • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
    • apply externally to the affected area up to 4 times daily, especially at night or in the morning or after each bowel movement.
    • apply externally or in the lower portion of the anal canal only.
    • 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.

    Children under 12 years of age: consult a doctor.

  • Other Information

    store at room temperature 68° - 77° F (20° - 25° C).

  • Inactive ingredients

    aloe barbadensis leaf extract, carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80, water, xanthan gum

  • Questions?

    1-800-639-3803 Weekdays 9 AM to 4 PM EST

  • DOSAGE & ADMINISTRATION

  • PRINCIPAL DISPLAY PANEL

    Hemorrhoidal Cream Package

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL CREAM 
    glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-1503(NDC:70000-0425)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE0.28 g  in 28 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN4.032 g  in 28 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.07 g  in 28 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM4.2 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67296-1503-228 g in 1 TUBE; Type 0: Not a Combination Product04/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/03/2019
    Labeler - Redpharm Drug Inc. (828374897)
    Establishment
    NameAddressID/FEIBusiness Operations
    Redpharm Drug Inc.828374897repack(67296-1503)
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