Label: HIBISCUS COCONUT HAND SANITIZER- alcohol solution

  • 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 April 21, 2015

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  • Drug Facts

    Active Ingredients

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on the skin and clean hands.
    • Recommended for repeated use.
  • Warnings

    For external use only.

    Flammable. Keep away from fire or flame.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • WHEN USING

    Do not get into eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Discontinue use if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor.

  • Directions

    • apply to hands until thoroughly wet
    • rub vigorously until dry
    • supervise children in the use of this product.
  • Other information

    • may discolor certain fabrics or surfaces.
    • do not store above 110°F (43°C)
  • Inactive ingredients

    Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Helianthus Annus) Seed Extract, Grapefruit (Citrus Grandis) Seed Extract, Yellow 5 (CI 19140), Yellow 6 (CI 15985).

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Brands International Corp.
    Markham, ON, L6G 1B9 Canada
    www.brandsicorp.com

  • Package Label

    HIBISCUS COCONUT

    ANTIBACTERIAL

    Hand Sanitizer Gel


    Kills 99.99% of Germs
    1 FL OZ (29 ml)

    Label

  • INGREDIENTS AND APPEARANCE
    HIBISCUS COCONUT HAND SANITIZER  
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-105
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-105-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/20/2015
    Labeler - Brands International (243748238)
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