Label: PREPARATION H MAXIMUM STRENGTH- glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream

  • NDC Code(s): 0573-2868-10, 0573-2868-20, 0573-2868-93, 0573-2868-98
  • Packager: Wyeth Consumer Healthcare 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 May 12, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Glycerin 14.4%Protectant
    Phenylephrine HCl 0.25%Vasoconstrictor
    Pramoxine HCl 1%Local anesthetic
    White petrolatum 15%Protectant
  • INDICATIONS & USAGE

    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

    Warnings

    For external use only

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the 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.

  • DOSAGE & ADMINISTRATION

    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
  • STORAGE AND HANDLING

    Other information

    store at 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum

  • QUESTIONS

    Questions or comments?

    Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

  • PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

    PREPARATION H®

    HEMORRHOIDAL
    CREAM

    Multi-Symptom
    Pain Relief

    WITH
    ALOE

    New Look,
    SAME SIZE!

    • Soothing Pain Relief from Burning,
      Itching, & Discomfort
    • Shrinks Swollen Hemorrhoidal Tissue
    • Protects Irritated Tissue
    • Relieves External Discomfort
    • Proprietary Blend with Vitamin E
      and Aloe

    1 TUBE | NET WT 0.9 OZ (26 g)

    PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
  • PRINCIPAL DISPLAY PANEL - 51 g Tube Carton

    PREPARATION H®
    HEMORRHOIDAL CREAM

    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

    NET WT. 1.8 OZ (51 g)

    PRINCIPAL DISPLAY PANEL - 51 g Tube Carton
  • PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - NDC 0573-2868-98

    PREPARATION H®

    HEMORRHOIDAL
    CREAM

    Multi-Symptom
    Pain Relief

    WITH
    ALOE

    • Soothing Pain Relief from Burning,
      Itching, & Discomfort
    • Shrinks Swollen Hemorrhoidal Tissue
    • Protects Irritated Tissue
    • Relieves External Discomfort
    • Proprietary Blend with Vitamin E
      and Aloe

    1 TUBE | NET WT 1.8 OZ (51 g)

    PRINCIPAL DISPLAY PANEL - 51 g Tube Carton - NDC 0573-2868-98
  • INGREDIENTS AND APPEARANCE
    PREPARATION H   MAXIMUM STRENGTH
    glycerin, petrolatum, phenylephrine hcl, pramoxine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2868
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LAURETH-23 (UNII: N72LMW566G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2868-101 in 1 CARTON07/01/2004
    126 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0573-2868-201 in 1 CARTON07/01/2004
    251 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0573-2868-931 in 1 CARTON01/01/2019
    326 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0573-2868-981 in 1 CARTON05/12/2020
    451 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34607/01/2004
    Labeler - Wyeth Consumer Healthcare LLC (828831730)
    Establishment
    NameAddressID/FEIBusiness Operations
    PF Consumer Healthcare Canada ULC203812479ANALYSIS(0573-2868) , LABEL(0573-2868) , MANUFACTURE(0573-2868) , PACK(0573-2868)