Label: ITCH X- benzyl alcohol/pramoxine hydrochloride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 2, 2022

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  • ACTIVE INGREDIENT

    Active ingredients......................................Purpose

    Benzyl alcohol 10%......................................Topical analgesic
    Pramoxine hydrochloride 1%.......................Topical analgesic

  • PURPOSE

    Use

    Temporarily relieves pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac

  • INDICATIONS & USAGE

    Use

    Temporarily relieves pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac

  • WARNINGS

    Warnings

    • For external use only.
    • Avoid contact with eyes.
  • DO NOT USE

    Do not use

    • on open wounds, damaged, or blistered skin.
    • for vaginal, genital, or rectal itching.
    • on children under 2 years of age unless under the advice and supervision of a physician.
  • ASK DOCTOR

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • STOP USE

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of reach of children. In case of ingestion, get medical help or contact a poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years and older - apply to affected area not more than 3 or 4 times daily
    • children under 2 years - consult a physician
  • STORAGE AND HANDLING

    Other information

    • store at 59°-86° F (15°-30° C) in a dry place
    • mfd. in the USA for B.F. Ascher & Co., Inc.
  • INACTIVE INGREDIENT

    Inactive ingredients: aloe barbadensis leaf juice (aloe vera gel), blue 1, butylene glycol, carbomer, citric acid, diazolidinyl urea, iodopropynyl butylcarbamate, potassium sorbate, SD alcohol 40, sodium benzoate, sodium sulfite, styrene/acrylates copolymer, tetrahydroxypropyl ethylenediamine, and water

  • QUESTIONS

    Questions? Call 1-800-324-1880, 7:30am - 4:00pm Central, M - F, or visit bfascher.com

  • PRINCIPAL DISPLAY PANEL

    Itch-X Gel PDP

    Itch-X Gel PDP

  • INGREDIENTS AND APPEARANCE
    ITCH X 
    benzyl alcohol/pramoxine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0225-0495
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL10 g  in 100 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE (UNII: V5VD430YW9)  
    WATER (UNII: 059QF0KO0R)  
    EDETOL (UNII: Q4R969U9FR)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STYRENE/AMMONIUM ACRYLATE COPOLYMER (300000 MW) (UNII: PA4J9TF5U2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0225-0495-3335.4 g in 1 TUBE; Type 0: Not a Combination Product09/19/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/19/2014
    Labeler - BF ASCHER AND CO INC (003854403)
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