ISOPROPYL ALCOHOL LIQUID [DYAD MEDICAL SOURCING, LLC]

ISOPROPYL ALCOHOL LIQUID [DYAD MEDICAL SOURCING, LLC]
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NDC 53175-810-43
Set ID b5c9e222-10eb-4cea-af70-213a77fcc865
Category HUMAN OTC DRUG LABEL
Packager Dyad Medical Sourcing, LLC
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active Ingredient

    Isopropyl alcohol70%

  • Purpose

    First aid antiseptic

  • Use

    First aid to help prevent the rist of infection in:

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only.  Will product serious gastric disturbances if taken internally

    Flammable Keep away from fire or flame, heat, spark, electrical

  • Ask a doctor before use

    for deep or puncture wounds, animal bites or serious burns

  • When using this product

    • do not get into eyes
    • do not apply over large areas of the body
    • do not use longer than 1 week
  • Stop use and ask a doctor if

    condition persists or gets worse

  • Keep out of reach of children.

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

    Caution – Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

  • Directions

    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Other information

    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • Inactive ingredient

    water

  • Adverse Reaction

    Pat. D675,101

    Manufactured for: Dyad Medical Sourcing, LLC

    2101 Waukegan Road, Suite 208, Bannokburn, IL 60015

    1-855-241-1773, info@dyadms.com

    Made in the USA with US and foreign components

    452.000/810AA

  • principal display panel

    HCS

    Reorder NO HCS0203

    70%

    Isopropyl

    Rubbing

    Alcohol

    First Aid Antiseptic

    • For treatment of mnor cuts and scrapes
    • Decreases germs in minor cuts
    • For external use only

    WARNING FLAMMABLE - Keep away from heat, spark, electrical, fire or flame

    Use only in well-ventilated area; fumes can be harmful

    16 FL OZ (1PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53175-810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53175-810-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2018
    Labeler - Dyad Medical Sourcing, LLC (078572603)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(53175-810)

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