DK12 SHOWER GEL CREAMY- 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.

----------

DK12 Shower Gel Creamy

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

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)

Revised: 9/2023
Document Id: 05e36111-ed4f-12de-e063-6294a90af639
Set id: 05e36111-ed4e-12de-e063-6294a90af639
Version: 1
Effective Time: 20230921
 
Industria La Popular, S.A.