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

  • NDC Code(s): 69396-033-18
  • Packager: Trifecta Pharmaceuticals Usa Llc
  • 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 January 9, 2021

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 cleaning wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream.

    When first opening 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

  • Warnings

    For External Use Only

    Ask doctor brfore use if you have

    Heart Disease

    Thyroid Disease

    Diabetes

    Trouble urinating due to an enlarged prostate gland

    Ask doctor before use if you are presently 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)

    Do not use if tube seal is broken or missing

    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, glyceryl monostearate, methylparaben, mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum

  • Questions or Comments

    Call 1-888-296-9067

  • Distributed By

    Trifecta Pharmaceuticals USA™

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301, USA

    1-888-296-9067

    Product of PRC

    www.trifecta-pharma.com

  • Packaging

    Hemorrhoidal Cream

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL CREAM 
    glycerol, phenylephine, pramoxine, petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN14.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-033-181 in 1 BOX01/25/2019
    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 finalpart34601/25/2019
    Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)