Label: DK12 SHOWER GEL FRESH ENERGY- benzalkonium chloride 0.13% gel

  • NDC Code(s): 62476-011-16
  • 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, Cocomide MEA, Cocamidopropyl Betaine, Sodium Lauryl Sarcosinate, Fragrance (Parfum), Glycereth-26, Aqua/Pentylene Glycol/Glycerin/Fructose/Urea/Citric Acid/Sodium

    Hydroxide/Maltose/Sodium PCA/Sodium Chloride/Sodium Lactate/Trehalose/Allantoin/Sodium Hyaluronate/Glucose, Trideceth-9/PEG-5 Isononanoate/Aqua, Aloe Barbadensis Leaf Extract,

    Sodium Chloride, Menthol/Menthyl Lactate, Polyquaternium-10, Citric Acid, Phenoxyethanol, Methylcloroisothiazolinone/Methylisothiazolinone, Aqua/Betula Lenta Bark Oil/Vetiveria Zizanoides Root Oil/Linoleic Acid/Oleic Acid/Polysorbate 80/Phenoxyethanol/Caprylyl Glycol/BHT, D&C Green No. 5

  • DK12 Shower Gel Fresh Energy

    labellabel

  • INGREDIENTS AND APPEARANCE
    DK12 SHOWER GEL FRESH ENERGY 
    benzalkonium chloride 0.13% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62476-011
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    UREA (UNII: 8W8T17847W)  
    TREHALOSE (UNII: B8WCK70T7I)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    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)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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)  
    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)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    ALLANTOIN (UNII: 344S277G0Z)  
    MALTOSE (UNII: XJ6S9RV06F)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62476-011-16500 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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