Label: CROWN SOLUTIONS INSTANT HAND SANITIZER 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 14, 2021

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

  • DRUG FACTS

  • ACTIVE INGREDIENT

    Ethyl Alcohol 62% (v/v)

    PURPOSE

    Antibacterial

  • USES:

    Hand sanitizer to reduce bacteria on the skin

  • WARNINGS:

    For external use only 

    Flammable: Keep away from fire or flame

    when using this product.

    Avoid contact with eyes. In case of eye contact, flush with water.

    Stop use and if

    irritation and redness develop and persist for more than 3 days.

    Keep out of reach of children

    If swallowed, get medical help or contact a poison control center right away

  • DIRECTIONS:

    Apply a small amount unto hands, rub in hands thoroughly until dry. No rinsing required

  • OTHER INFORMATION :

    Do not store above 120 degrees F

  • INACTIVE INGREDIENTS:

    water, acrylates/SC 10-30 cross polymer, glycerin, propylene glycol, aloe barbadensis leaf juice, ammomethyl propanol, fragrance 

  • Package Labeling: 118 ml

    Bottle

    box

  • Package Labeling: 236 ml

    Bottle2

    box

  • Package Labeling: 946 ml

    Bottle3

    box

  • Package Labeling: 3784 ml

    Bottle4

    box

  • Package Labeling: 946000 ml

    Bottle5

    box

  • INGREDIENTS AND APPEARANCE
    CROWN SOLUTIONS INSTANT HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81570-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81570-001-0124 in 1 BOX09/04/2021
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:81570-001-0224 in 1 BOX09/04/2021
    2236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:81570-001-034 in 1 BOX09/04/2021
    3946 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:81570-001-044 in 1 BOX09/04/2021
    43784 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:81570-001-051 in 1 BOX09/04/2021
    5946000 mL in 1 TANK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/04/2021
    Labeler - RAF, LLC (007736291)