Label: ABOVE HAND SANI ANTISEPTIC- benzalkonium chloride aerosol, foam

  • Category: HUMAN OTC DRUG LABEL

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 August 19, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride (0,10%)

    Purpose

    antiseptic

  • Uses

    Hand sanitizer to help decrease bacteria on the skin. Recommended for repeated use

  • Warnings

    FLAMMABLE. DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING. CAN CAUSE SERIOUS INJURY OR DEATH

    • KEEP AWAY FROM FACE AND MOUTH TO AVOID CONTACT 

    DO NOT USE

    IN OR NEAR THE EYES. IN CASE OF CONTACT WITH EYES, RINSE THOROUGHLY WITH WATER. CONTENTS UNDER PRESSURE. DO NOT
    PUNCTURE OR INCINERATE. DO NOT EXPOSE TO HEAT, SUNLIGHT OR STORE AT TEMPERATURES ABOVE 120°F/50°C OR IN ENCLOSED PLACES THAT COULD OVERHEAT

    • DO NOT USE ON BROKEN SKIN.

    STOP USE IF

    RASH OR IRRITATION OCCURS. GET MEDICAL ATTENTION IMMEDIATELY

    KEEP OUT OF REACH OF CHILDREN

    AND ANIMALS USE ONLY AS DIRECTED. FOR EXTERNAL USE ONLY. IF SWALLOWED, DO NOT INDUCE VOMITING. CONSULT YOUR HEALTHCARE PROVIDER IMMEDIATELY DO NOT LEAVE THE AEROSOL CONTAINER IN A VEHICLE. RISK OF LEAKAGE AND EXPLOSION. CONTAINER MATERIAL: ALUMINUM BATCH AND EXPIRATION ON THE BOTTOM OF THE CONTAINER.

  • Directions

    Shake well before using. Put a small amount in your palm and rub hands together briskly until dry, always holding the container in an upright position. No rinsing required. No towels needed. 

  • Inactive ingredients

    AQUA / ALCOHOL / BUTANE / PROPANE / GLYCERIN / ISOBUTANE / COCAMIDOPROPYL BETAINE / TOCOPHERYL ACETATE / PEG-12 DIMETHICONE / IMIDAZOLIDINYL UREA / SODIUM BENZOATE / PROPYLENE GLYCOL / ALOE BARBADENSIS EXTRACT / SODIUM CHLORIDE / MELALEUCA ALTERNIFOLIA LEAF OIL / EUGENIA CARYOPHYLLUS LEAF OIL / SODIUM CITRATE / BENZOIC ACID / CITRIC ACID / PARFUM (BENZYL BENZOATE / CITRAL / CITRONELLOL /GERANIOL / LIMONENE / HEXYL CINNAMAL / LINALOOL).

  • Questions?

    e-mail support@myspray.group or call: +1 (305) 677-5030

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ABOVE HAND SANI ANTISEPTIC 
    benzalkonium chloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73306-6001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOBUTANE (UNII: BXR49TP611)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    IMIDUREA (UNII: M629807ATL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    CITRAL (UNII: T7EU0O9VPP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73306-6001-1130 g in 1 CAN; Type 0: Not a Combination Product08/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/14/2020
    Labeler - Baston Industria De Aerossols Ltda (897727605)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!