Label: GUARDIAN GEL- alcohol gel

  • 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 September 22, 2020

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  • Active Ingredient(s)

    Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Use (s)

    Hand rub to help reduce bacteria that potentially can cause disease.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • When using this product

    Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use and ask a doctor

    If irritation or rash occurs. These may be signs of a serious condition.

  • Keep out of reach of children

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Acrylic Polymer, Glycerin, Aloe Vera, Triethanolamine,Vitamin E, Aqua

  • Questions or Comments?

    Call 1-888-505-7178

  • Principal Display Panel

    NDC Numbers 79209-001-02, 79209-001-03, 79209-001-04, 79209-001-05, 79209-001-06 and 79209-001-07

    70% Alcohol Gel with Aloe and Vitamin E.

    GUARDIAN GEL

    HAND SANITIZER

    Unscented

    2.25 mL (.07 oz)

    250 mL (8.4 oz)

    500 mL (16.9 oz)

    1L (33 oz)

    50 Gallon Barrel

    1000L Tote

    Vegan, Cruelty free, Paraben Free, Sulfate free, Caffeine free, Phthalate free, Triclosan-free.

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  • INGREDIENTS AND APPEARANCE
    GUARDIAN GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79209-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79209-001-020.00225 L in 1 PACKAGE; Type 0: Not a Combination Product09/22/2020
    2NDC:79209-001-030.25 L in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    3NDC:79209-001-040.5 L in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    4NDC:79209-001-051 L in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    5NDC:79209-001-06189.2711 L in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    6NDC:79209-001-071000 L in 1 BOTTLE; Type 0: Not a Combination Product09/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/22/2020
    Labeler - Guardian Marine, LLC (020371465)
    Registrant - Guardian Marine, LLC (020371465)
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