Label: ITCH-X- pramoxine hcl/benzyl alcohol spray

  • 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 October 25, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients.............. Purpose
    (in solution)
    Benzyl alcohol 10%............Topical analgesic
    Pramoxine HCl 1%..............Topical analgesic

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  • INDICATIONS & USAGE

    Uses temporarily relieves pain and itching associ- ated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac.

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  • PURPOSE

    Uses temporarily relieves pain and itching associ- ated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac.

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  • WARNINGS

    Warnings


    For external use only.
    Avoid contact with eyes.
    Keep away
    from fire or flame.

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  • ASK DOCTOR

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a physician.

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  • DO NOT USE

    Do not apply to open wounds, damaged, or blistered skin.

    Do not use for vaginal, genital, or rectal itching.

    Do not use on children under 2 years of age unless under the advice and supervision of a physician.

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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • 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.
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  • STORAGE AND HANDLING

    Other information

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


    Inactive ingredients aloe barbadensis (aloe vera gel), SD alcohol 40, and water

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  • QUESTIONS

    Questions?

    1-800-324-1880, 7:30am - 4:00pm Central, Mon. - Fri., or visit www.bfascher.com

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  • PRINCIPAL DISPLAY PANEL

    Itch-X Spray PDP

    Itch-X Spray PDP

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  • INGREDIENTS AND APPEARANCE
    ITCH-X 
    pramoxine hcl/benzyl alcohol spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0225-0516
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 1 g  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL 10 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALOE (UNII: V5VD430YW9)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0225-0516-51 59.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/19/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 09/19/2014
    Labeler - BF ASCHER AND CO INC (003854403)
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