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 November 29, 2017

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  • ACTIVE INGREDIENT:

    Pramoxine hydrochloride 1%.

  • INACTIVE INGREDIENTS:

    Cetyl alcohol, emulsifying wax, methylparaben, polyoxyethylene C12-C14 ether, PPG5 Ceteth-20, propylene glycol, propylparaben, purified water, sorbitan trioleate, trolamine, and inert propellant: tetrafluoroethane.

  • INDICATION:

    Use for the temporary relief of pain and itching associated with hemorrhoids.

  • DIRECTIONS: SHAKE WELL BEFORE USE.

    Dispense Pramoxine Hydrochloride 1% onto a clean tissue or pad and apply externally to the affected area up to 5 times daily. See carton for additional directions for use.

  • 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. Certain persons can develop allergic reactions to 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 immediately and consult a physician. Do not use in the eyes or nose. Do not apply to large areas of the body.

  • CAUTION: FOR EXTERNAL USE ONLY.

    Do not insert any part of the aerosol container into the rectum. 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).

    STORE UPRIGHT AT CONTROLLED ROOM TEMPERATURE 20°-25°C (68°-77°F). DO NOT REFRIGERATE.

  • PURPOSE

  • STOP USE

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Mayne Pharma
    Greenville, NC 27834

    Net Wt. 0.53 oz (15 g)

    HOLD UPRIGHT TO DISPENSE

  • PRINCIPAL DISPLAY PANEL - 15 g Container Carton

    NDC 51862-180-15

    Pramoxine
    Hydrochloride 1%

    For external use only
    Hemorrhoidal Foam-Non Steroid

    SHAKE WELL BEFORE USING

    Net Wt. 0.53 oz. (15 g)

    Foam

    maynepharma

    PRINCIPAL DISPLAY PANEL - 15 g Container Carton
  • INGREDIENTS AND APPEARANCE
    PRAMOXINE HYDROCHLORIDE 
    pramoxine hydrochloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51862-180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CETETH-20 (UNII: I835H2IHHX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TETRAFLUOROMETHANE (UNII: 94WG9QG0JN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51862-180-151 in 1 CARTON10/31/2011
    115 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34610/31/2011
    Labeler - Mayne Pharma (867220261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sciarra Laboratories, Inc.824900369MANUFACTURE(51862-180) , PACK(51862-180) , LABEL(51862-180)
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