Label: SIMPLY SALINE WOUND CARE- benzethonium chloride 0.13% spray

  • NDC Code(s): 10237-700-71
  • Packager: Church & Dwight Co., Inc.
  • 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 18, 2018

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  • Wound Care 3 in 1 Active ingredients

    Benzethonium Chloride 0.13%

  • Purpose

    First aid Antiseptic

  • Uses

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

  • Warnings For external use only.

    Do not use

    • in the eyes or apply over large areas of the body
    • longer that 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

    When using this product

    • do not puncture or incinerate
    • store between 59 and 86F (15 and 30C)
    • contents under pressure
  • STOP USE

    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

    • before use, expel a short stream of Wound Care to clear nozzle
    • 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 information

    for single patient use only

  • Inactive ingredients

    aloe barbadensis leaf extract (aloe vera), benzalkonium chloride, maltodextrin, purified water, sodium bicarbonate, sodium chloride

  • Product Image

    Sting Free

    Arm and Hammer

    The standard of Purity

    Simply Saline

    First Aid Antiseptic

    Wound Care

    3 in 1

    Irrigates

    Helps prevent infections

    Soothes

    Plus Soothing Aloe

    7.4 FL OZ (211 mL)

    Image

    SACN-08557-05E.jpg

  • INGREDIENTS AND APPEARANCE
    SIMPLY SALINE  WOUND CARE
    benzethonium chloride 0.13% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1 mg  in 13 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-700-71211 mL in 1 CAN; Type 0: Not a Combination Product05/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/2012
    Labeler - Church & Dwight Co., Inc. (001211952)
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