Label: PREPARATION H RAPID RELIEF- lidocaine, phenylephrine hydrochloride spray

  • NDC Code(s): 0573-2890-01, 0573-2890-02
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 29, 2024

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  • Active ingredients

    Lidocaine 5%

    Phenylephrine HCl 0.25%

  • Purposes

    Local anesthetic

    Vasoconstrictor

  • INDICATIONS & USAGE

    Uses

    • Helps relieve the local discomfort and itching associated with hemorrhoids
    • For the temporary relief of pain, soreness or burning
    • Temporarily reduces the swelling associated with irritation in hemorrhoids
    • Temporarily shrinks hemorrhoidal tissue
  • WARNINGS

    Warnings

    For external use only

    Flammable:Do not use while smoking or near heat or flame

    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 arepresently 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 this product into the rectum by using fingers or any mechanical device or applicator
    • Warning -avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.
    • Warning -use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    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 pad
    • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
    • Shake well before using
    • Hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired
    • Apply externally to the affected area up to 4 times daily
    • Children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    Other information

    • Store at 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe barbadensis leaf juice, citric acid, disodium EDTA, glycerin, isobutane, malic acid, menthol, propyl gallate, propylene glycol, SD alcohol 40-B, sodium benzoate, water

  • QUESTIONS

    Questions or comments?

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

  • Additional Information

    No-Touch Spray

    Do not use if clear safety seal around cap is broken or missing

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies.

    @2021 GSK or licensor

    For most recent product information, visit www.preparationh.com

  • PRINCIPAL DISPLAY PANEL

    NEW!

    PREPARATIONH

    RAPID RELIEF
    WITH
    LIDOCAINE

    HEMORRHOIDAL SPRAY

    LIDOCAINE
    PHENYLEPHRINE HCl

    • Rapid numbing relief of pain,

      itching and burning

    • Reduces swelling of
      inflamed tissue
    • Highest strength lidocaine

      available

    NET WT 3.8 OZ (107.7 g)

    000070918 Front Label

    PrepH Relief Spray with Lidocaine 3.8 oz(107.7 g)
  • INGREDIENTS AND APPEARANCE
    PREPARATION H RAPID RELIEF 
    lidocaine, phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2890
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOBUTANE (UNII: BXR49TP611)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2890-01107.7 g in 1 CANISTER; Type 0: Not a Combination Product02/01/2022
    2NDC:0573-2890-02127.6 g in 1 CANISTER; Type 0: Not a Combination Product02/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01502/01/2022
    Labeler - Haleon US Holdings LLC (079944263)
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