Label: BARE HANDS- hand sanitizer 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 May 18, 2020

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  • Active Ingredient

    Ethyl Alcohol 62%

    Purpose

    Antiseptic

  • Uses

    to help reduce bacteria on the skin.

    recommended for repeated use

  • Warnings

    For external use only

    Flammable. Keep away from fire/flame.

    When using this product do not use in or near the eyes. In case of eye contact, rinse thoroughly with water.

    Stop use and ask a dotor if irritaion or rash appears and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under 6 years of age should be supervised.

  • Directions

    Dispense an adequate amount in your hands and rub hands together until dry. Does not require rinising.

  • Other information

    Do not store above 104 F (40 C). May discolor certain fabrics or surfaces.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Water

  • 3.4 fl oz bottle label

    3.4 fl oz bottle label

  • INGREDIENTS AND APPEARANCE
    BARE HANDS 
    hand sanitizer spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76150-239
    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
    CHAMOMILE (UNII: FGL3685T2X)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76150-239-04100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2020
    Labeler - Bell International Labroatories, Inc. (967781555)
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