Label: SOMBRA ANTIBACTERIAL 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 29, 2020

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  • Active Ingredients

    Ethyl Alcohol 65% v/v

  • Uses

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

  • Warnings

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

  • Do not use

    avoid contact with broken skin. Do not inhale or ingest.  Children under 6, use only
    under adult supervision.  Not recommended for infants.

  • When Using

    When using this product, keep out of the eyes. In case of contact with eyes, flush thoroughly with water.

  • STOP USE

    Stop use if irritation and redness develop or if 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.

  • Storage and Handling

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

  • Inactive ingredients

    glycerin, purified water, isopropyl alcohol, aminomethyl propanol, citrus limon (lemon) peel oil, citrus aurantium dulcis (orange) peel oil, yucca schidigera stem extract,  rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, filipendula ulmaria (queen of the prairie) extract, camellia sinensis (green tea) leaf extract, aloe barbadensis leaf extract.

  • Purpose

    Antiseptic

  • PRINCIPAL DISPLAY PANEL

    Sombra Economy Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    SOMBRA ANTIBACTERIAL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-4130
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LEMON PEEL (UNII: 72O054U628)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)  
    FILIPENDULA ULMARIA WHOLE (UNII: 3LH0M209LN)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-4130-13785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2020
    2NDC:61577-4130-6473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/29/2020
    3NDC:61577-4130-8237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/29/2020
    Labeler - SOMBRA COSMETICS (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS097464309manufacture(61577-4130)
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