Label: NE MEXICO AGING LONG TERM SERVICES DEPARTMENT HAND SANITIZER- benzalkonium chloride 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 September 3, 2021

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  • Active Ingredients

    Benzalkonium Chloride 0.15%

  • Uses

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

  • Warnings

    For external use only: hands.

  • 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 childrenn

    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 inder 6, use only under adult supervision.

  • Storage and Handling

    Store away from oxidizing agents. Do not store above 100 C.

  • Inactive ingredients

    Purified water, glycerin, cyamopsis tetragonoloba (Guar) gum, citrus limon (lemon) peel oil, hamamelis virginiana (witch hazel) leaf extract, camellia sinensis (green tea) leaf extract, champmilla recutita (matricaria) flower extract, rosa damascena (rose) flower waterr, aloe barbadensis leaf juice, yucca schidigera stem extract, filipendula ulmaria (queen of the prairie) extract, phenoxyethanol, caprylyl glyol, citric acid

  • Purpose

    Anitmicrobial

  • PRINCIPAL DISPLAY PANEL

    New Mexico Aging and Long Term Services Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    NE MEXICO AGING LONG TERM SERVICES DEPARTMENT HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-4200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GUAR GUM (UNII: E89I1637KE)  
    LEMON OIL (UNII: I9GRO824LL)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    CHAMOMILE (UNII: FGL3685T2X)  
    YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)  
    FILIPENDULA RUBRA WHOLE (UNII: MT26BL24AZ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-4200-8237 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/03/2021
    Labeler - Sombra Cosmetics (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sombra Cosmetics097464309manufacture(61577-4200)
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