FDA.reportPublic FDA data

DK12 Shower Gel Fresh Energy

Manufacturer
Industria La Popular, S.A.
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:39:58

Label at a glance#

ProductDK12 Shower Gel Fresh Energy
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

For washing to decrease bacteria on the skin

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

For washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For External Use only.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

irritation or redness develops - condition persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION


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

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62476-011-16DK12 Shower Gel Fresh Energy500 mL in 1 BOTTLEGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62476-011DK12 SHOWER GEL FRESH ENERGY (BENZALKONIUM CHLORIDE 0.13%) GEL [INDUSTRIA LA POPULAR, S.A.]2Current NDC, 1 package rows20241204_05e4ff0e-ef63-ef3b-e063-6294a90aa2b8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62476-01162476-011-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
SODIUM LAURYL SARCOSINATE5PGH842FAUIACT
SODIUM CHLORIDE451W47IQ8XIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
UREA8W8T17847WIACT
TREHALOSEB8WCK70T7IIACT
POLYQUATERNIUM-10 (400 CPS AT 2%)HB1401PQFSIACT
COCAMIDE3YXD33R71GIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
SODIUM LAURYL SULFATE368GB5141JIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
D&C GREEN NO. 58J6RDU8L9XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BETULA LENTA BARKJ689T0DVJQIACT
POLYSORBATE 806OZP39ZG8HIACT
PENTYLENE GLYCOL50C1307PZGIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LACTATETU7HW0W0QTIACT
SODIUM PIDOLATE1V74VH163TIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
LINOLEIC ACID9KJL21T0QJIACT
OLEIC ACID2UMI9U37CPIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
TRIDECETH-9X9HD79I514IACT
VETIVERIA ZIZANIOIDES ROOT37TB8LUP9ZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
FRUCTOSE6YSS42VSEVIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
ALLANTOIN344S277G0ZIACT
MALTOSEXJ6S9RV06FIACT
GLYCERETH-26NNE56F2N14IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DK12 Shower Gel Fresh EnergyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.05e4ff0e-ef63-ef3b-e063-6294a90aa2b82024-12-02WarningsExact identifier
ndc (package): 62476-011-16
ndc (product): 62476-011
ndc11 (package): 62476001116
spl id: 284c576c-3bfc-f6c2-e063-6394a90a2535
spl set id: 05e4ff0e-ef63-ef3b-e063-6294a90aa2b8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.