Label: PRAMOXINE HYDROCHLORIDE aerosol, foam

  • 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 23, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pramoxine hydrochloride 1%

  • Purpose

    Local Anesthetic

  • Use

    for the temporary relief of pain and itching associated with hemorrhoids

  • Warnings

    Do not exceed the recommended daily dosage unless directed by a physician.

    If condition worsens or does not improve within 7 days, consult a physician.

    In case of rectal bleeding, consult a physician promptly.

    Do not put this product into the rectum by using fingers or any mechanical device or applicator. Do not insert any part of the aerosol container into the rectum.

    Certain persons can develop allergic reactions to the ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a physician.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place cap on container. Shake well before use.
    • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
    • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of proctofoam®.
    • Dispense proctofoam® onto a clean tissue and apply externally to the affected area up to 5 times daily.
    • Children under 12 years of age: consult a physician.
  • Other information

    • Store upright at controlled room temperature 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F).
    • Do not refrigerate.
    • Contents of the container are under pressure. Do not burn or puncture the aerosol container.
    • Do not store at temperatures above 120°F (49°C).
  • Inactive ingredients

    cetyl alcohol, glyceryl monostearate and PEG-100 stearate blend, methylparaben, polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, trolamine and inert propellants: isobutane and propane.

  • Questions?

    1-888-317-0001

  • SPL UNCLASSIFIED SECTION

    ALAVEN®
    PHARMACEUTICAL LLC
    Marietta, GA 30067, USA

    Rev. 08/08



    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma        74146

  • PRINCIPAL DISPLAY PANEL - 15 g Carton

    NDC 54868-5865-0

    Principal Display Panel - 15 g Carton
    STORE UPRIGHT

    proctofoam®
    non-
    steroid
    (pramoxine hydrochloride 1%)

    hemorrhoidal foam

    For temporary
    relief of
    hemorrhoidal
    pain and itching

    For External Use Only

    15 g net wt (0.53 oz)

  • INGREDIENTS AND APPEARANCE
    PRAMOXINE HYDROCHLORIDE 
    pramoxine hydrochloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5865(NDC:68220-143)
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    pramoxine hydrochloride (UNII: 88AYB867L5) (pramoxine - UNII:068X84E056) pramoxine hydrochloride150 mg  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    cetyl alcohol (UNII: 936JST6JCN)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    methylparaben (UNII: A2I8C7HI9T)  
    polyoxyl 40 stearate (UNII: 13A4J4NH9I)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    trolamine (UNII: 9O3K93S3TK)  
    isobutane (UNII: BXR49TP611)  
    propane (UNII: T75W9911L6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5865-01 in 1 CARTON
    115 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34602/22/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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