Label: PROCTOFOAM NS- pramoxine hydrochloride aerosol, foam

  • Category: HUMAN OTC DRUG LABEL

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 July 27, 2018

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  • Active ingredient

    Pramoxine hydrochloride 1%

  • Purpose

    Local anesthetic

  • Use

    for the temporary relief of pain and itching associated with hemorrhoids

  • Warnings

    For external use only

    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
    •
    do not insert any part of the aerosol container into the rectum

    Stop use and ask a doctor if

    •
    rectal bleeding occurs
    •
    condition worsens or does not improve within 7 days
    •
    allergic reaction occurs to the ingredients in this product
    •
    symptom being treated does not subside
    •
    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.

  • 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
    •
    dispense 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° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 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 49°C (120°F)
  • Inactive ingredients

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

  • Questions?

    1-888-350-1908

     

    Distributed by:
    Meda Pharmaceuticals Inc.
    Somerset, New Jersey 08873-4120

    © 2021 Viatris Inc.

    PROCTOFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company..

  • Principal Display Panel – 1%

    NDC 0037-6823-15

    TAMPER EVIDENT FEATURE: Do not use if Meda Pharmaceuticals® seal on ends of carton are broken or missing.

    proctofoam® non-steroid
    pramoxine hydrochloride 1%
    hemorrhoidal foam

    For temporary
    relief of
    hemorrhoidal
    pain and itching

    STORE
    UPRIGHT

    NET WT.
    0.53 OZ (15 g)

    Proctofoam Foam 1% Carton Label
  • INGREDIENTS AND APPEARANCE
    PROCTOFOAM  NS
    pramoxine hydrochloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0037-6823
    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)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LAURETH-23 (UNII: N72LMW566G)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPANE (UNII: T75W9911L6)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0037-6823-151 in 1 CARTON08/18/2014
    115 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/18/2014
    Labeler - Meda Pharmaceuticals (051229602)
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