Label: PROSORIA ANTI-ITCH MOISTURIZER- pramoxine hydrochloride lotion

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

Drug Label Information

Updated January 10, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pramoxine HCL 1%

  • Purpose

    External analgesic

  • Use

    for the temporary relief of itching associated with minor skin irritations

  • Warnings

    For external use only

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and consult a doctor if

    • the condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days.

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

  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor
  • Inactive ingredients

    Water, White Petrolatum, Glycerin, PEG-100 Stearate, Glyceryl Stearate SE, Stearic Acid, Copaifera Coriacea Resin Oil, Tetrahydrodiferuloylmethane, Cetyl Alcohol, Stearyl Alcohol, Phenoxyethanol, Vitamin E (Tocopheryl acetate), Xanthan Gum, Sodium Citrate, Disodium EDTA.

  • Questions?

    Visit www.prosoria.com or call toll-free 1-833-776-7483 Mon – Fri, 8am – 5pm CT.

  • SPL UNCLASSIFIED SECTION

    Distributed by Nuvothera, Inc.
    Fort Worth, Texas 76104

  • PRINCIPAL DISPLAY PANEL - 90 mL Bottle Label

    moisturizes
    relieves itching

    prosoriä

    anti-itch
    moisturizer

    Pramoxine Hydrochloride 1%

    external analgesic

    3 FL OZ (90mL)

    Principal Display Panel - 90 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PROSORIA ANTI-ITCH MOISTURIZER 
    pramoxine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71573-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride0.9 g  in 90 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cetyl alcohol (UNII: 936JST6JCN)  
    COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)  
    Tetrahydrodiferuloylmethane (UNII: 00U0645U03)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71573-120-1190 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01504/01/2022
    Labeler - Nuvothera, Inc. (080499864)
    Establishment
    NameAddressID/FEIBusiness Operations
    Quality CDMO117658386MANUFACTURE(71573-120)
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