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

  • NDC Code(s): 0573-2843-01, 0573-2843-10
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) 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 November 4, 2020

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

  • Active Ingredients

    Glycerin 14.4%

    Lidocaine 5%

    Phenylephrine HCl 0.25%

    White petrolatum 15%

  • Purposes

    Protectant

    Local anesthetic

    Vasoconstrictor

    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 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
  • 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

    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)

    Preparation H Rapid Relief w PE 23 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    PREPARATION H RAPID RELIEF 
    glycerin, lidocaine, petrolatum, and phenylephrine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2843
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 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)  
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2843-011 in 1 CARTON11/01/2018
    123 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0573-2843-101 in 1 CARTON11/01/2018
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34611/01/2018
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    PF Consumer Healthcare Canada ULC203812479ANALYSIS(0573-2843) , LABEL(0573-2843) , MANUFACTURE(0573-2843) , PACK(0573-2843)