Label: ARAMARK ISOPROPYL- isopropyl 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 May 26, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Isopropyl Alcohol 70%

  • Purpose

    First Aid Antiseptic

  • Uses

    First aid to help prevent infection in minor cuts,

    scrapes and burns

  • Warnings

    For external use only.

    Flammable keep away from fire or flame.

    Do not use

    • near eyes or mucous membranes • on deep or

    puncture wounds, animal bites, or serious burns

    Keep out of reach of children

    Caution • not for use on large areas of the body • if

    redness, irritation, swelling or pain persists in increases,

    discontinue use and consult a physician.

  • Directions

    • spray over cleaned affected area 1 to 3 times daily

  • Inactive ingredients

    purified water

  • Package Labeling

    aramark

    Isopropyl

    Alcohol Spray

    For Aid to Help
    Prevent Infection in
    Minor Cuts, Scrapes
    and Burns

    2 fl. oz. (59.1ml)
    Reorder no. 53002

    MANUFACTURED FOR:
    Aramark
    Lenexa, KS 66219  886-362-2691

    5500-2 Alcohol Spray

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  • INGREDIENTS AND APPEARANCE
    ARAMARK ISOPROPYL 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-5500
    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:81238-5500-259.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/28/2021
    Labeler - Western First Aid Safety DBA Aramark (043861524)
    Registrant - Western First Aid Safety DBA Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(81238-5500)