Label: NATURAL CONCEPTS NON-ALCOHOL FOAMING HAND SANITIZER- benzalkonium chloride solution

  • 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 April 15, 2020

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  • Active ingredient

    Benzalkonium Chloride 0.1%

    Purpose

    Antiseptic

  • Uses

    to help decrease bacteria on the skin. For use when soap and water are not available.

  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Do not use

    • on children less than 2 months of age
    • on open wounds

    Stop using this product and ask a doctor if

    irritation or redness develops and lasts more than 7 days.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • pump enough product to your palm to thoroughly cover your hands, rub together for at least 30 seconds, until dry.
    • children under 6 years should be supervised when using this product.
  • Other information

    store at room temperature.

  • Inactive ingredients

    Water (Aqua), Polysorbate 20, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Fragrance (Parfum), Camellia Sinensis Leaf Extract, DMDM Hydantoin, Sodium Hydroxide, Blue 1 (CI 42090), Yellow 5 (CI 19140).

  • Questions or comments?

    1-866-695-3030

  • Labe Copy

    image of the label

  • INGREDIENTS AND APPEARANCE
    NATURAL CONCEPTS NON-ALCOHOL FOAMING HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-513
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-513-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2020
    2NDC:63148-513-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2020
    3NDC:63148-513-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/14/2020
    Labeler - Apollo Health and Beauty Care Inc. (201901209)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(63148-513)
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