Label: CANDO HAND SANITIZER- alcohol gel

  • 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 23, 2020

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  • Active Ingredients

    Ethyl Alcohol 70%

  • 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

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

  • When Using

    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

    Stop use and ask a doctor if irritation and redness develop. Condition persists more than 72  hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.  For children under 6, use only under adult supervision.  Not recommended for infants.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Other information

    Do not store above 105F.  May discolor some fabrics.  Harmful to wood finishes and plastics.

  • Inactive ingredients

    glycerin, purified water, isopropyl alcohol, polyacrylate crosspolymer-6, rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, aloe barbadensis leaf juice, citrus aurantium dulcis (orange) peel oil, citrus limon (lemon) peel, oil, yucca schidigera stem extract, filipendula rubra extract, camellia sinensis (green tea) leaf extract.

  • Purpose

    Antiseptic

  • PRINCIPAL DISPLAY PANEL

    Los Poblanos 8oz gel

  • INGREDIENTS AND APPEARANCE
    CANDO HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-1116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    FILIPENDULA RUBRA WHOLE (UNII: MT26BL24AZ)  
    LEMON PEEL (UNII: 72O054U628)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-1116-8236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    2NDC:61577-1116-259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    3NDC:61577-1116-3946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    4NDC:61577-1116-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    5NDC:61577-1116-6473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/15/2020
    6NDC:61577-1116-13785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/15/2020
    Labeler - SOMBRA COSMETICS (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS097464309manufacture(61577-1116)
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