Label: EXTREME SANITIZER- hand sanitizer liquid

  • 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 December 28, 2020

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  • Extreme Sanitizer®

    Extreme Sanitizer®

    Extreme Sanitizer®

    Kills 99.99% of Germs in 15 Seconds

    Effective Hand Sanitizer

    Advanced Formula

    KILLS CORONAVIRUS IN 15 SECONDS

    Hypoallergenic and ALCOHOL-FREE

    Drug Facts

    Active Ingredient:Alkylbenzyldimethylammonium
    Chloride (Quaternary Ammonium) 0.13%…Antiseptic
    Use: For hand sanitation. No water wash.
    WARNING: Avoid eye contact, flush with
    water. Keep out of reach of children.
    STOP use if redness or irritation occurs.
    Call poison control if swallowed.
    Directions:Apply spray to full cover hands
    and rub. Repetition increases the effect.
    Inactive Ingredient: Water
    Questions? info@extremesanitizer.com
    Other information: Store at 56 – 86 oF

    Earth Wind Fire L.L.C. The Woodlands, TX. 77382

    www.extremesanitizer.com

    2 FL OZ
    (60 mL)

    Active Ingredient

    Active Ingredient:Alkylbenzyldimethylammonium
    Chloride (Quaternary Ammonium) 0.13%…Antiseptic

    Active Ingredient

    Dosage and administration

    Active Ingredient:Alkylbenzyldimethylammonium
    Chloride (Quaternary Ammonium) 0.13%…Antiseptic

    Use: For hand sanitation. No water wash.

    Directions:Apply spray to full cover hands
    and rub. Repetition increases the effect.

    Dosage and Admin

    Warning

    WARNING: Avoid eye contact, flush with
    water. Keep out of reach of children.

    Warning

    Other Information

    Other information: Store at 56 – 86 oF

    Other Info

    Questions

    Questions? info@extremesanitizer.com Questions

    Use and Purpose

    Antiseptic
    Use: For hand sanitation. No water wash.

    Use

    Warning

    WARNING: Avoid eye contact, flush with
    water. Keep out of reach of children.

    Waring

    Do Not Use Stop Use

    WARNING: Avoid eye contact, flush with
    water. Keep out of reach of children.
    STOP use if redness or irritation occurs.
    Call poison control if swallowed.

    Do not Use

    Stop Use

    WARNING: Avoid eye contact, flush with
    water. Keep out of reach of children.
    STOP use if redness or irritation occurs.
    Call poison control if swallowed.

    Stop Use

    Warning

    WARNING: Avoid eye contact, flush with
    water. Keep out of reach of children.

    No children

    Stop Use

    STOP use if redness or irritation occurs.
    Call poison control if swallowed.

    Stop Use

    Indication and Usage

    Use: For hand sanitation. No water wash.

    Directions:Apply spray to full cover hands
    and rub. Repetition increases the effect.

    Indication and usage

    Inactive Ingredients

    Inactive Ingredient: Water

    Inactive Ingredient

  • INGREDIENTS AND APPEARANCE
    EXTREME SANITIZER 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77868-0001
    Route of AdministrationCUTANEOUS, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77868-0001-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
    2NDC:77868-0001-2250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
    3NDC:77868-0001-3500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
    4NDC:77868-0001-41000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/30/2020
    5NDC:77868-0001-53875.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/30/2020
    Labeler - Earth Wind Fire L.L.C. / Extreme Sanitizer® (111867055)