Label: SOMBRA HAND SANITZER- 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 July 22, 2020

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  • Active Ingredient

    Ethyl Alcohol 65%

  • Purpose

    Antiseptic

  • Uses

    To decrease bacteria and viruses on the skin that could cause disease. Recommended for repeated use.

  • Warnings

    Flammable. Keep away from fire or flame. For external use only:  hands.

  • Do not use

    Stop use and ask doctor if, irritation and redness develop condition persists for more than 72 hours.

  • When using this product

    When using this product, keep out of the eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

  • Stop use and ask a doctor

    Stop use and ask doctor if, irritation and redness develop 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.

  • Other Information

    Do not store above 105F.  May discolor some fabrics.  May harm wood finishes.

  • Inactive ingredients

    Aloe Barbadensis leaf juice, Citrus Aurantium Dulce (orange) Peel Oil, Glycerin, Isopropyl Alcohol, Purified Water, Rosa Damascena Flower Water, Hamemelis Viginiara Leaf Extract, Yucca Schidigera Root Extract.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SOMBRA HAND SANITZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-4129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-4129-2118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/22/2020
    Labeler - SOMBRA COSMETICS (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS097464309manufacture(61577-4129) , label(61577-4129)
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