Label: PRAX- pramoxine hydrochloride lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

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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

    Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Mineral Oil, PEG-100 Stearate, Phenoxyethanol, Purified Water, Stearyl Alcohol, White Petrolatum, Xanthan Gum

  • Package Label

    Questions or comments call 1-855-361-3993.

    Manufactured for:

    AvKARE

    Pulaski, TN 38478

    www.avkare.com

    AV 01/2022

    1

  • INGREDIENTS AND APPEARANCE
    PRAX 
    pramoxine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-682
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-682-15237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/11/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/11/2022
    Labeler - AvPAK (832926666)
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