PREPARATION H RAPID RELIEF (GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE) CREAM [WYETH CONSUMER HEALTHCARE LLC]

  • Home
  • PREPARATION H RAPID RELIEF (GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE) CREAM [WYETH CONSUMER HEALTHCARE LLC]

PREPARATION H RAPID RELIEF (GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE) CREAM [WYETH CONSUMER HEALTHCARE LLC]
PDF | XML
NDC 0573-2843-01, 0573-2843-10
Set ID 699310e8-1a93-40b4-a8f4-a765be4a0cb1
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist, Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
View All Sections
  • 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)
View All Sections

Related Drugs

Search DailyMed Drugs