DK12 SHOWER GEL FRESH ENERGY- benzalkonium chloride 0.13% gel 
Industria La Popular, S.A.

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.

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DK12 Shower Gel Fresh Energy

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

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)

Revised: 9/2023
Document Id: 05e54056-4279-dcf4-e063-6294a90ae1a2
Set id: 05e4ff0e-ef63-ef3b-e063-6294a90aa2b8
Version: 1
Effective Time: 20230921
 
Industria La Popular, S.A.