Label: RAW SPIRIT - MOISTURIZING HAND SANITIZER FOAM- benzalkonium chloride liquid

  • 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 July 16, 2020

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS:

  • ACTIVE INGREDIENTS

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • USES

    To decrease bacteria on the skin.

  • WARNINGS

    For external use only: Hands only.

    • When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Avoid contact with broken skin.

    • Stop use and ask a doctor if irritation or redness develops - condition persists 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 and allow to dry without wiping - for children under 6, use only under adult supervision - not recommended for infants

  • INACTIVE INGREDIENTS

    Water (Aqua), Propanediol, Glycereth-7 Triacetate, Glycerin, Babassu Oil Glycereth-8 Esters, Decyl Glucoside, Calendula Officinalis Flower Extract, Equisetum Arvense Extract, Geranium Maculatum Extract, Honey, Citric Acid, Panax Ginseng Root Extract, Salvia Officinalis Leaf Extract, Sambucus Nigra Flower Extract, Ethylhexylglycerin, Phenoxyethanol, Sodium Hydroxide.

  • PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label

    RAW
    SPIRIT

    moisturizing
    antimicrobial
    foam

    4.1 fl. oz | 120ml

    PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    RAW SPIRIT - MOISTURIZING HAND SANITIZER FOAM 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-1901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propanediol (UNII: 5965N8W85T)  
    Glycereth-7 Triacetate (UNII: S9W6Z48HUP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Babassu Oil Glycereth-8 Esters (UNII: 12XQ76K0YL)  
    Decyl Glucoside (UNII: Z17H97EA6Y)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    Equisetum Arvense Branch (UNII: 1L0VKZ185E)  
    Geranium Maculatum Root (UNII: 93IXI5B6OJ)  
    Honey (UNII: Y9H1V576FH)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Asian Ginseng (UNII: CUQ3A77YXI)  
    Sambucus Nigra Flower (UNII: 07V4DX094T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-1901-1120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E06/01/2020
    Labeler - Cosmetic Solutions LLC (807907928)
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