Label: GIR THE GUARDIAN GEL SANITIZE- hand sanitizer 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 January 12, 2021

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Alcohol 65% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • 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

    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 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 Poison Control Center right away.

  • STOP USE

    Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    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 product to avoid swallowing.

  • Other information

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

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Carthamus Tinctorius (Safflower) Seed Oil, Fragrance, Geranium Maculatum Extract, Glycerin, Lavandula Angustifolia (Lavender) Flower Extract, Propanediol, Tocopheryl Acetate, Water (Aqua).

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    GIR THE GUARDIAN GEL SANITIZE 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72496-1125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL35 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 35 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72496-1125-1236 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2021
    Labeler - Naturich Labs (124281663)
    Registrant - Naturich Labs (124281663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Naturich Labs124281663manufacture(72496-1125)