Label: GENRX ALL PURPOSE CLEANSING- benzalkonium chloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antiseptic

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  • Uses

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

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  • 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

    Stop use and ask a doctor if

    ■ condition worsens
    ■ symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • 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)
    ■ apply GenRx protectant cream or paste as necessary

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  • Other information

    ■ protect from freezing    ■ avoid excessive heat

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  • Inactive ingredients

    Aloe barbadensis (Aloe vera) leaf juice, butylene glycol, disodium EDTA, fragrance, glycerin, 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], phenoxyethanol, polysorbate 20, purified water, sodium hyaluronate, sodium hydroxide.

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  • GenRx All Purpose Cleansing Spray (8 oz label)
  • INGREDIENTS AND APPEARANCE
    GENRX ALL PURPOSE CLEANSING 
    benzalkonium chloride spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-543
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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, DL- (UNII: WR1WPI7EW8)  
    GINGER (UNII: C5529G5JPQ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59088-543-16 237 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 01/08/2013
    Labeler - PureTek Corporation (785961046)
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