ROYAL ALCOHOL CLEANSING PADS (ISOPROPYL ALCOHOL) LIQUID [FILO AMERICA]

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ROYAL ALCOHOL CLEANSING PADS (ISOPROPYL ALCOHOL) LIQUID [FILO AMERICA]
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NDC 50438-000-00
Set ID 18b3c907-b85c-4c90-8840-d8ec79a6a567
Category HUMAN OTC DRUG LABEL
Packager Filo America
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ROYAL ALCOHOL CLEANSING PADS


  • Active Ingredient

    Isopropyl Alcohol, 70% v/v

  • Purpose

    Antiseptic

  • Use

    for the preparation of skin prior to an injection to decrease germs in minor cuts and scrapes.

  • Warning:

    For external use only

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center immediately.

    Caution

    do not apply to irritated skin.

    Do not use

    in the eyes or on mucous membranes.

    In case

    of deep cuts or puncture wounds, consult a doctor.

  • Direction

    wipe injection site vigorously.

  • Other information

    store at room temperature.

  • Inactive ingredient

    water

  • PRINCIPAL DISPLAY PANEL

    ROYAL ALCOHOL CLEANSING PADS

    PRE-MOISTENED WIPES FOR EVERYDAY USE

    • Individually foil wrapped
    • 70% Isopropyl Alcohol

    100 INDIVIDUAL PACKS
    SAFE AND EAST TO USE
    STERILE unless individual wrapper is opened or damaged.

  • ROYAL ALCOHOL CLEANSING PADS 100 Packs (50438-000-00)

    Outer Label

  • INGREDIENTS AND APPEARANCE
    ROYAL ALCOHOL CLEANSING PADS 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50438-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.45 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50438-000-00100 in 1 PACKAGE
    10.45 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/29/2013
    Labeler - Filo America (943873703)
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