Label: CAREFUL HAND SANITIZER ORANGE- ethyl alcohol spray

  • 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 26, 2021

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  • Drug Facts

  • Active Ingredient:

    Ethyl alcohol 80% v/v

  • Purpose

    Antiseptic

  • Uses

    • for hand washing to decrease bacteria on the skin. • recommended for repeated use throughout the day

  • Warnings

    For external use only

    Flammable. Keep away from fire or flame.

    When using this product avoid contact with eyes. In case of contact, flush eyes thoroughly with water.

    Stop use and contact a doctor if irritation or redness develop or lasts for more than 72 hours.

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

  • Directions

    • wet hands thoroughly with product • allow to dry without wiping • supervise children under 6 years old • not recommended for infants

  • Other information

    • may discolor certain fabrics • store at room temperature 20° - 25°C (66° - 77° F)

  • Inactive Ingredients

    Aqua (Water), Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Simmondsia Chinensis (Jojoba) seed oil, Parfum, Panthenol, Tocopheryl Acetate (Vitamin E).

  • SPL UNCLASSIFIED SECTION

    With Moisturizing Jojoba Oil, Aloe Vera and Vitamin E

    Orange

    Kills 99.9% of germs

    Sold and distributed by Careful Co.
    Seattle, WA 98109

    SKU: CRFSPHSO2011-1

    Not tested on animals

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    CAREFUL HAND SANITIZER ORANGE 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80622-555
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80622-555-121 in 1 CARTON01/20/2021
    1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/20/2021
    Labeler - Brainstem Innovations Co. (117436122)
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