Label: COLEMERG 75 ALCOHOL SANITIZING- 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 February 18, 2021

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 75%

    Purpose

    Antiseptic

  • Uses

    • Decreases bacteria on the skin
    • Recommended for repeated use
  • Warnings

    • Extermely flammable aerosol, keep away from fire / flame.
    • Keep away from heat, hot surfaces, open flames and other ignition sources.
    • Pressurized contiainer, Do not pierce or burn, even after use.
    • Protect from the sunlight.
    • For external use only

    Do not use

    • On children less than 2 months of age
    • On open skin wounds

    When using this product

    • Avoid use on/or around eyes, ears, mouth, broken/irritated skin or large areas of body.
    • In case of contact with eyes, rinse thoroughly with water for several minutes.
    • Do not inhale or ingest

    Stop and ask a doctor if

    • Irritation persist
    • If product is swallowed

    Keep out of reach of children.

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

  • Directions

    • Shake well before use.
    • Hold can upright at 6-7 inches away from surfaces and spray evenly.
    • Allow to air dry for 5 to 10 minutes. Repeat application as necessary.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other Information

    • Store between 15-30° C (59-86°F)
    • Do not expose to temperature exceeding 50 C/122 F.
  • Inactive Ingredients

    Butane, Fragrance, Isobutane, Propane.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    COLEMERG 75 ALCOHOL SANITIZING 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81547-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPANE (UNII: T75W9911L6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81547-001-01547 mL in 1 CAN; Type 0: Not a Combination Product10/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/25/2020
    Labeler - KSMT COMPANY INCORPORATED (117858077)
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