Label: HEMORRHOIDAL CREAM WITH ALOE- glycerol, phenylephine, pramoxine, petrolatum cream

  • NDC Code(s): 83324-044-09
  • Packager: Chain Drug Marketing Association
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2025

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

  • Drug Facts

  • Active Ingredient

    Glycerol 14.4%

  • Purpose

    Protectant

  • Active Ingredient

    Phenylephrine HCI 0.25%

  • Purpose

    Vasoconstrictor

  • Active Ingredient

    Pramoxine HCI 1%

  • Purpose

    Local Anesthetic

  • Active Ingredient

    Petrolatum 15%

  • Purpose

    Protectant

  • Uses

    Helps relieve the local itching and discomfort associated with hemorrhoids

    Temporarily shrinks hemorrhoidal tissue and relieves burning

    Temporarily provides a coating for relief of anorectal discomforts

    Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

  • Stop use and ask a doctor

    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 doctor 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, clean the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream.

    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

  • Warnings

    For External Use Only

    Ask doctor brfore use if you have

    Heart Disease

    Thyroid Disease

    Diabetes

    Difficulty urinating due to an enlarged prostate gland

    Ask doctor before use if you arepresently taking a prescription 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

  • Other Information

    Store at room temperature 20º-25ºC (68º-77ºF)

    This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H®

  • Inactive Ingredients

    Aloe barbadensis leaf juice, carboxmethylcellulose sodium, cetyl alcohol, mono and diglycerides, methylparaben, mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum

  • Questions or Comments

    Call 1-800-935-2362

  • Distributed By

    CDMA Inc.®

    Novi, MI.48375, USA

    800-935-2362

    www.qualitychoice.com

  • Packaging

    99125 QC HEMORRHOIDAL CREAM WITH ALOE 0.9OZ REV08 050624 CDER

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL CREAM WITH ALOE 
    glycerol, phenylephine, pramoxine, petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM15 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
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN14.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONO- AND DICAPRYLATE (UNII: 34966F76M6)  
    CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%) (UNII: 99H65D77XY)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-044-091 in 1 BOX07/08/2019
    125.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01507/07/2019
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Trifecta Pharmaceuticals USA (079424163)