Label: 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 November 19, 2020

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  • Active Ingredient(s)

    0.3% Benzalkonium chloride

  • Purpose

    Use when needed.

  • DIRECTIONS

    Spray hand sanitizer in the palm of your hands.
    Rub briskly product onto hands and allow to dry.

  • Warnings

    For external use only. Avoid contact with eyes. If contact occurs, flush eyes with water. If the condition persists, consult a doctor.
    If swallowed immediately call a poison control center or a doctor for treatment advice.

  • Do not use

    /

  • WHEN USING

    For external use only. Avoid contact with eyes. If contact occurs, flush eyes with water. If the condition persists, consult a doctor.

  • STOP USE

    If swallowed immediately call a poison control center or a doctor for treatment advice.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Spray hand sanitizer in the palm of your hands.
    Rub briskly product onto hands and allow to dry.

  • Other information

    Store at temperatures below 30°C.

  • Inactive ingredients

    Water, Glycerine, Decyl Glucoside, Aloe Vera, Fructooligosaccharide, Fragrance

  • Package Label - Principal Display Panel

    25040050100

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14341-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 100 mL
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 0.01 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14341-006-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    2NDC:14341-006-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    3NDC:14341-006-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    4NDC:14341-006-04400 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/20/2020
    Labeler - Ningbo Venus Cosmetic Co., Ltd. (421364944)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Venus Cosmetic Co., Ltd.421364944manufacture(14341-006)
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