Label: ESSENTIALS BY CATALINA HAND SANITIZER- alcohol 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 May 7, 2020

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

  • Active Ingredients[s]

    Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use[s]

    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

    • on 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 thoroughtly with water.

  • STOP USE

    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

    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 15-30°C (59-86°F)
    • Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive Ingredients

    Deionized Water, Glycerin, Propylene Glycol, Organic Aloe Barbadensis (Aloe Vera) Leaf Extract, Panthenol (Pro-Vitamin B5), Tocopheryl Acetate (Vitamin E Acetate), Carbomer

  • PRINCIPAL DISPLAY PANEL

    275 Gallon Tank (Tote) of Hand Sanitizer55 Gallon Drum of Hand Sanitizer5 Gallon Pail of Hand Sanitizer1 Gallon Jug of Hand Sanitizer8 oz Bottle of Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    ESSENTIALS BY CATALINA HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76902-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYQUATERNIUM-37 (3000 MPA.S) (UNII: HU373G0YSU) 0.62 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.18 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.8 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.32 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.02 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.06 mL  in 100 mL
    PANTHENOL (UNII: WV9CM0O67Z) 0.01 mL  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) 0.01 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76902-025-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/11/2020
    2NDC:76902-025-023785 mL in 1 JUG; Type 0: Not a Combination Product05/11/2020
    3NDC:76902-025-0318927 mL in 1 PAIL; Type 0: Not a Combination Product05/11/2020
    4NDC:76902-025-04208197 mL in 1 DRUM; Type 0: Not a Combination Product05/11/2020
    5NDC:76902-025-051040987 mL in 1 TANK; Type 0: Not a Combination Product05/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/11/2020
    Labeler - Maki Creations, Inc. (080478763)
    Establishment
    NameAddressID/FEIBusiness Operations
    Maki Creations, Inc.080478763manufacture(76902-025)