ITCH-X (PRAMOXINE HCL/BENZYL ALCOHOL) SPRAY [BF ASCHER AND CO INC]

ITCH-X (PRAMOXINE HCL/BENZYL ALCOHOL) SPRAY [BF ASCHER AND CO INC]
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NDC 0225-0516-51
Set ID 03f85dbb-a13a-3126-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager BF ASCHER AND CO INC
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

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

  • 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.

  • 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.

  • WARNINGS

    Warnings


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

  • 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.

  • 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.

  • 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 overdose or ingestion of contents, 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)
    • mfd. in the USA for B.F. Ascher & Co., Inc.
  • INACTIVE INGREDIENT


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

  • QUESTIONS

    Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Itch-X Spray PDP

    Itch-X Spray PDP

  • INGREDIENTS AND APPEARANCE
    ITCH-X 
    pramoxine hcl/benzyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0225-0516
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 mL
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE (UNII: V5VD430YW9)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0225-0516-5159.1 mL in 1 BOTTLE, SPRAY; 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)