ISOPROPYL ALCOHOL SWAB [LERNAPHARM LORIS INC.]

ISOPROPYL ALCOHOL SWAB [LERNAPHARM LORIS INC.]
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NDC 68356-117-02
Set ID 4f5d9224-63d8-4256-a5ea-b2d16ccbb89b
Category HUMAN OTC DRUG LABEL
Packager LernaPharm Loris Inc.
Generic Name
Product Class
Product Number
Application Number PART333
  • Active Ingredient (in each swab)

    Isopropyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses


    For preparation of the skin prior to an injection. Helps reduce bacteria that potentially can cause skin infection.

  • Warnings

    Flammable, keep away from fire or flame. Do not use with electrocautery procedures. For external use only. Do not use in the eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Tear open individual swab and apply product to the injection site prior to an injection. Rub skin briskly in circular motion from injection site outward.

  • Other Information

    Store at room temperature between 59 - 86 0F (15 - 30 0C)

  • Inactive Ingredients

    Purified water

  • Questions or comments?

    Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST

  • Principal Display Panel

    image of outer box packagingimage of individual swab packageNDC 68356-117-02 PRODUCT # 117-02U


    LORIS - ALCOHOL SWABS


    MEDIUM

    Saturated with 70% v/v isopropyl alcohol, USP

    Single use only ● For external use only ● Easy to use ● Economical

    Antiseptic

    Non-Sterile Solution and Swab


    200 units

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68356-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68356-117-02200 in 1 BOX09/10/2019
    10.238 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/04/2010
    Labeler - LernaPharm Loris Inc. (206940905)
    Establishment
    NameAddressID/FEIBusiness Operations
    LernaPharm Loris Inc.206940905manufacture(68356-117) , pack(68356-117) , label(68356-117)

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