Label: SALINE WOUND WASH SIGNATURE CARE- benzethonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 January 31, 2018

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  • ACTIVE INGREDIENT

    Active ingredient                                                                             Purpose
    Benzethonium Chloride 0.13%.........................................................Topical anesthetic

  • PURPOSE

  • Uses

    First aid to help prevent the rick of bacterial contamination in minor cuts, scrapes and burns

  • WARNINGS

    Warnings
    For external use only.

    Do not use in the eyes • longer than 1 week
    When using this product  avoid spraying in eyes

    Do not puncture or incenerate. Contents under pressure. Do not store at temperature above 120F
    Stop use and ask a doctor if • condition worsens or persists

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • clean the affected area
    • spray a small amount of this product on the area 1 to 3 times a day
    • may be covered with steriline bandage
    • if bandage, let dry first
  • Inactive ingredients

    BENZALKONIUM CHLORIDE

    ALOE VERA LEAF

    water

    SODIUM BICARBONATE

    SODIUM CHLORIDE

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SALINE WOUND WASH  SIGNATURE CARE
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-762
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzethonium Chloride (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) Benzethonium Chloride0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    water (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-762-05201 g in 1 CAN; Type 1: Convenience Kit of Co-Package03/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2018
    Labeler - Better Living (009137209)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(21130-762) , label(21130-762)
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