Label: PREPARATION H RAPID RELIEF- glycerin, lidocaine, petrolatum, and phenylephrine hydrochloride cream

  • NDC Code(s): 0573-2843-01, 0573-2843-10
  • 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 January 22, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purposes
    Glycerin 14.4% Protectant
    Lidocaine 5% Local anesthetic
    Phenylephrine HCl 0.25% Vasoconstrictor
    White petrolatum 15% Protectant
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  • 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
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  • 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.

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  • 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 this cream.
    • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • children under 12 years of age: ask a doctor
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  • STORAGE AND HANDLING

    Other information

    store at 20-25°C (68-77°F)

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  • 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

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  • QUESTIONS

    Questions or comments?

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

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  • PRINCIPAL DISPLAY PANEL - 23 g Tube Label

    To open: push down on cap while turning counterclockwise.

    Child-Resistant Cap

    PREPARATION H®

    HEMORRHOIDAL CREAM

    RAPID RELIEF
    WITH LIDOCAINE

    • Rapid numbing relief of pain, itching & burning
    • Reduces swelling & provides a soothing
      protective layer

    NET WT 0.75 OZ (23g)

    Principal Display Panel - 23 g Tube Label
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  • PRINCIPAL DISPLAY PANEL - 23 g Tube Carton

    PREPARATION H®

    New Benefit
    Now Reduces Swelling
    See new label

    RAPID RELIEF
    WITH
    LIDOCAINE

    HEMORRHOIDAL
    CREAM

    LIDOCAINE
    PHENYLEPHRINE HCl
    GLYCERIN
    WHITE PETROLATUM

    5%
    HIGHEST STRENGTH
    LIDOCAINE
    AVAILABLE

    • Rapid numbing relief of pain,
      itching & burning
    • Reduces swelling & provides
      a soothing protective layer

    1 TUBE | NET WT 0.75 OZ (23 g)

    Principal Display Panel - 23 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    PREPARATION H RAPID RELIEF 
    glycerin, lidocaine, petrolatum, and phenylephrine hydrochloride cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-2843
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 144 mg  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 50 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 150 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    LAURETH-23 (UNII: N72LMW566G)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0573-2843-01 1 in 1 CARTON 11/01/2018
    1 23 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:0573-2843-10 1 in 1 CARTON 11/01/2018
    2 28 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part346 11/01/2018
    Labeler - Wyeth Consumer Healthcare LLC (828831730)
    Establishment
    Name Address ID/FEI Business Operations
    PF Consumer Healthcare Canada ULC 203812479 ANALYSIS(0573-2843) , LABEL(0573-2843) , MANUFACTURE(0573-2843) , PACK(0573-2843)
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