Label: SIMPLY SALINE PLUS WOUND WASH ANTIBACTERIAL FIRST AID ANTISEPTIC- benzethonium chloride spray

  • 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 November 29, 2011

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  • Active ingredient

    Benzethonium Chloride 0.13%

  • Uses

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

  • Purpose

    First aid Antispetic

  • Warnings For external use only

    Do not use

    • in the eyes or apply over large areas of the body
    • longer than 1 week, unless directed by a doctor
  • Ask a doctor before use if you have

    • deep or puncture wounds, animal bites or serious burns

    When using this product
    • do not puncture or incinerate
    • store between 50 and 86 degrees F (15 and 30 C)
    • contents under pressure
    Stop use and consult a doctor if
    • condition persists or gets worse
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • 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 a sterile bandage
    • if bandaged, let dry first
  • OTHER SAFETY INFORMATION

    Other information

    for single patient use only

  • Inactive ingredients

    benzalkonium chloride, purified water, sodium bicarbonate, sodium chloride

  • Principal Display

    ARM and HAMMER
    THE STANDARD OF PURITY

    Simply
    Saline
           plus

    Wound Wash
    Antibacterial         First Aid
                             Antiseptic

    pressurized
    saline wash

    helps remove
    dirt and debris

    STING-FREE

    3.0 FL OZ (90 mL)

    Can imageCan image

  • INGREDIENTS AND APPEARANCE
    SIMPLY SALINE PLUS WOUND WASH  ANTIBACTERIAL FIRST AID ANTISEPTIC
    benzethonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-694
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.13 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-694-3090 mL in 1 CAN
    2NDC:10237-694-71210 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2010
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.117337220manufacture
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