Label: MOISTURIZING ANTIBACTERIAL HAND SANITIZER- moisturizing antibacterial hand sanitizer gel 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 December 3, 2020

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  • Active Ingredient(s)

    BENZALKONIUM CHLORIDE 0.13%

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria on skin

  • Warnings

    For external use only, Keep out of reach of children.

  • Do not use

    do not use in or near the eyes. In case of contaot, rinse eyes thoroughly with water.

  • WHEN USING

    When using this product,
    do not use in or near the eyes. In case of contaot, rinse eyes thoroughly with water.
    Stop use and ask doctor if imtation or rash appears and lasts.
    Keep out of reach for children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask doctor if imtation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach for children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Open the cap and gently squeeze product into palm of hands, then rub throughly over all surfaces of both hands.

  • Other information

    Store between 59-86F(15-30C). Avoid freezing and excessive heat above 104F (40C).

  • Inactive ingredients

    WATER (AQUA).
    FRAGRANCE (PARFUM), PHENOXYETHANOL,
    POLYQUATERNIUM-10, POLYSORBATE 20,
    TETRASODIUM EDTA.

  • Package Label - Principal Display Panel

    74743-017-01 50ML

  • INGREDIENTS AND APPEARANCE
    MOISTURIZING ANTIBACTERIAL HAND SANITIZER 
    moisturizing antibacterial hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74743-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74743-017-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Guangzhou Joy Claire Biological Technology Co.,Ltd (418209894)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Joy Claire Biological Technology Co.,Ltd418209894manufacture(74743-017)
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