Label: DK12 SHOWER GEL CREAMY- benzalkonium chloride 0.13% gel

  • NDC Code(s): 62476-010-16
  • Packager: Industria La Popular, S.A.
  • 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 September 21, 2023

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Uses

    For washing to decrease bacteria on the skin

  • Warnings

    For External Use only.

    When using this product

    avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.


    Stop use and ask a doctor

    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


    Apply to a body sponge on damp skin, rub into a rich lather all over the body, then rinse thoroughly.

  • Other Information

    Store between 15-30C (59-86F)

  • Inactive Ingredients

    Aqua, Sodium Lauryl Ether Sulfate, Cocamidopropyl B e t a i n e , L a u r y l G l u c o s i d e , G l y c o l
    Distearate/Laureth-4/Cocamidopropyl Betaine, Decyl Glucoside (and) Cocamidopropyl Hydroxysultaine (and) Cocamidopropyl Betaine (and) Cocamide MIPA (and) Disodium Laureth Sulfosuccinate (and) Disodium Lauryl Sulfosuccinate, Cocamidopropyl Betaine (and) Lauramide MIPA, Propylene Glycol, Disodium Cocoamphodiacetate, Sodium Lauryl Sarcosinate, Sodium Chloride, Jojoba Wax PEG-120 Esters, Aqua/Pentylene G l y c o l / G l y c e r i n / F r u c t o s e / U r e a / C i t r i c Acid/Sodium Hydroxide/Maltose/Sodium PCA/Sodium Chloride/Sodium Lactate/Trehalose/Allantoin/Sodium Hyaluronate/Glucose, Trideceth-9/PEG-5 Isononanoate/Aqua, Glycereth-26, Fragrance (Parfum), Citric Acid, Methylcloroisothiazolinone/Methylisothiazolinone, Tetrasodium EDTA, Aqua/Betula Lenta Bark Oil/Vetiveria Zizanoides Root Oil/Linoleic Acid/Oleic Acid/Polysorbate 80/ Phenoxyethanol/Caprylyl Glycol/BHT.

  • DK12 Shower Gel Creamy

    labellabel

  • INGREDIENTS AND APPEARANCE
    DK12 SHOWER GEL CREAMY 
    benzalkonium chloride 0.13% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62476-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.65 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    MALTOSE (UNII: XJ6S9RV06F)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMIDE (UNII: 3BD22052MO)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)  
    SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    UREA (UNII: 8W8T17847W)  
    TREHALOSE (UNII: B8WCK70T7I)  
    LAURETH-4 (UNII: 6HQ855798J)  
    COCAMIDE (UNII: 3YXD33R71G)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    BETULA LENTA BARK (UNII: J689T0DVJQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM PIDOLATE (UNII: 1V74VH163T)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    TRIDECETH-9 (UNII: X9HD79I514)  
    VETIVERIA ZIZANIOIDES ROOT (UNII: 37TB8LUP9Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62476-010-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/2023
    Labeler - Industria La Popular, S.A. (846044576)
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