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
- Purpose
- Uses
- Warnings
- Directions
- Other Information
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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
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INGREDIENTS AND APPEARANCE
DK12 SHOWER GEL FRESH ENERGY
benzalkonium chloride 0.13% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62476-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.65 g in 500 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:62476-011-16 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/01/2023 Labeler - Industria La Popular, S.A. (846044576)