Label: LE K - ESSENTIAL-DM ALOE VERA- benzalkonium chloride lotion
- NDC Code(s): 82822-001-01
- Packager: HCD ANTI AGING LABORATORIES LLC
- 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 July 22, 2022
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- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Aqua, Paraffinum Liquidum, Stearic Acid, Cetyl Alcohol, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Glycereth-26, Dimethicone, Glycol Stearate, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Sodium Hydroxide, Stearyl Alcohol, Parfum, Tocopheryl Acetate, Camelia Sinensis Extract, Rosmarinus Officinalis (Rosemary) Extract, Arnica Montana Flower Extract, Vitis Vinifera (Grape) Seed Extract, Propylene Glycol, FD&C Blue #1 (CI 42090), Geraniol, Hexyl Cinnamal, Amyl Cinnamal, Citronellol, Hydroxycitronnellal, Linalool, Coumarin.
- INDICATIONS & USAGE
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INGREDIENTS AND APPEARANCE
LE K - ESSENTIAL-DM ALOE VERA
benzalkonium chloride lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82822-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) STEARIC ACID (UNII: 4ELV7Z65AP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCOL STEARATE (UNII: 0324G66D0E) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF) LINALOOL, (+/-)- (UNII: D81QY6I88E) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) COUMARIN (UNII: A4VZ22K1WT) TRIDECETH-6 (UNII: 3T5PCR2H0C) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERETH-26 (UNII: NNE56F2N14) SODIUM HYDROXIDE (UNII: 55X04QC32I) ROSEMARY (UNII: IJ67X351P9) GERANIOL (UNII: L837108USY) VITIS VINIFERA SEED (UNII: C34U15ICXA) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) Product Characteristics Color blue Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82822-001-01 25 g in 1 POUCH; Type 0: Not a Combination Product 07/22/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/22/2022 Labeler - HCD ANTI AGING LABORATORIES LLC (118675977) Establishment Name Address ID/FEI Business Operations CHEMCO CORPORATION 032495954 manufacture(82822-001)
