Label: HYDROCLEAN HAND SANITIZER- benzalkonium chloride 0.13% gel

  • NDC Code(s): 73287-007-01, 73287-007-02, 73287-007-03, 73287-007-04, view more
    73287-007-05
  • Packager: Telebrands Corp
  • 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 May 21, 2020

If you are a consumer or patient please visit this version.

  • Active ingredient

    Benzalkonium Chloride 0.13% w/w

  • Purpose

    Benzalkonium Chloride 0.13% w/w...........................Antiseptic

  • Uses

    Antiseptic cleansing of hands and body to decrease bacteria on skin without soap and water.

  • Warnings

    For external use only

    Do not use

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

    When using this product keep out of eyes, ears, and mouth. In case of eye contact, flush eyes with water.

    Stop use and ask doctor if

    • irritation or rash occurs. These might be signs of a serious condition.
    • 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

    • Apply a small amount of gel into palm of hand. Rub thoroughly over all surfaces of both hands for 15 seconds. Allow hands to dry without wiping.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    Store tightly closed in a cool dry place.

  • Inactive ingredients

    Water/Aqua/Eau, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate, Cocos Nucifera (Coconut) Oil, Cannabis Sativa (Hemp) Seed Oil, Hydroxyethylcellulose, Polysorbate 20, Disodium EDTA, Sodium Citrate, Sodium Hydroxide, Citric Acid, Blue 1 (CI 42090), Yellow 5 (CI 19140).

  • Questions?

    Call (855) 877-4503 (M-F, 9am-5pm EST)

  • PRINCIPAL DISPLAY PANEL

    Handvana

    Odor Free

    HydroClean

    Hand Sanitizer

    Benzalkonium Chloride 0.13%

    KILLS 99.9% OF GERMS*

    Sanitize + Soften Hands

    With Moisturizing

    Coconut Oil

    Aloe Vera

    Hyaluronic Acid

    VALUE SIZE

    OVER 1lb

    17 fl oz (503 mL)

    Made in the USA

    GEL

  • INGREDIENTS AND APPEARANCE
    HYDROCLEAN HAND SANITIZER 
    benzalkonium chloride 0.13% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73287-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73287-007-011 in 1 CARTON04/08/2020
    1503 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:73287-007-021 in 1 CARTON05/15/2020
    23785 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:73287-007-031 in 1 CARTON05/15/2020
    3946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:73287-007-041 in 1 CARTON05/15/2020
    459 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:73287-007-051 in 1 CARTON05/15/2020
    5236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/08/2020
    Labeler - Telebrands Corp (177266558)
    Establishment
    NameAddressID/FEIBusiness Operations
    Neutraderm, Inc.146224444manufacture(73287-007)
    Establishment
    NameAddressID/FEIBusiness Operations
    A.I.G. Technologies Incorporated171837367manufacture(73287-007)