Label: PRAX- pramoxine hydrochloride lotion

  • NDC Code(s): 0496-0748-03, 0496-0748-04, 0496-0748-15
  • Packager: Ferndale Laboratories, Inc.
  • 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 18, 2019

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  • Active Ingredient

    pramoxine HCl 1% w/w

  • Purpose

    local anesthetic

  • Use

    for the temporary relief of discomfort and itch in the perianal area

  • Warnings

    For external use only.

    Do not

    • exceed the recommended daily dosage unless directed by a doctor
    • put this product into the rectum by using fingers or any mechanical device or applicator


    Stop use and ask a doctor if

    • condition worsens
    • symptoms do not improve within 7 days
    • allergic reactions develop to ingredients in this product
    • symptom being treated does not subside or if redness, irritation, swelling, pain, bleeding, or other symptoms develop or increase

    Keep out of reach of children.

    If swallowed, seek medical attention or contact a Poison Control Center right away.

  • Directions

    • Shake well before use.
    • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
    • Adults and children 12 years of age and older: apply to affected area up to 5 times daily.
    • Children under 12 years of age: consult a doctor.


  • Inactive Ingredients

    cetyl alcohol, di-isopropyl adipate, dimethicone, glycerin, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), mineral oil, polyoxyl 40 stearate, potassium sorbate, povidone, purified water, sorbic acid, stearic acid, and trolamine

  • Package Label

    Manufactured for
    Ferndale Healthcare® Inc.
    By Ferndale Laboratories, Inc.
    Ferndale, MI 48220 U.S.A.
    Toll Free (888) 548-0900
    www.ferndalehealthcare.com

    8 fl oz (237 mL) NDC 0496-0748-03

    PraxLotion8oz

  • INGREDIENTS AND APPEARANCE
    PRAX 
    pramoxine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0748
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0496-0748-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2012
    2NDC:0496-0748-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2012
    3NDC:0496-0748-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/01/2012
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferndale Laboratories, Inc.005320536manufacture(0496-0748)
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