Label: DIASINC- benzalkonium 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 March 23, 2023

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  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antiseptic

  • Uses

    ■ a no-rinse topical antiseptic that protects against bacterial contamination

  • Warnings

    For external use only

    Do not use on

    ■ deep or puncture wounds    ■ animal bites    ■ serious burns

    When using this product

    ■ do not get into eyes ■ If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    ■ If irritation or redness develops ■ 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

    ■ spray soiled and/or odorous (body and/or perineal) areas ■ gently wipe clean ■ repeat as necessary until all soils are removed and skin is clean ■ pat dry (no rinsing necessary)

  • Other information

    ■ Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. ■ protect from freezing ■ avoid excessive heat

  • Inactive ingredients

    aloe barbadensis (aloe vera) leaf juice, aqua (purified water), butylene glycol, disodium EDTA, fragrance, GenRx Complex® [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], glycerin, phenoxyethanol, polysorbate 20, sodium hyaluronate, sodium hydroxide.

  • DiaSinc™

    Label

  • INGREDIENTS AND APPEARANCE
    DIASINC 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-596
    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
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GINGER (UNII: C5529G5JPQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-596-16237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/24/2023
    Labeler - PureTek Corporation (785961046)
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