Label: BIOSILK- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 73740-4040-1, 73740-4040-5, 73740-4040-6 - Packager: Farouk Systems, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated March 31, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Inactive ingredients
Inactive infedients: Aqu,JWater/Eau, Sodium C14-16 Olefin Sulfonate,
Cocamidopropy Betaine, Glycenn, Melaleuca Alternifolia gea Tre Leaf Oil, Aloe Bart>adensis Leaf
Juice, Hydrolyzed Silk, Phenoxyehtanol, aprylyl lycol, Disodium, Laureth
Sulfosuccinate,Cetrimonium Chloride, Potassium Sorbate, TetrasodiumEDTA, Hexylene Glycol, Alcohol
Denat., Citric Acid, Sodium Chloride, Fragrance (Partum), Limonene, Cltral ID: 80-BSHSO - Active Ingredient
- Keep out of reach of Children
- Purpose
- Indications & Usage
- Warnings
- Storage and Handling
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Dosage & Administration
Active ingredient Purpose
BenzalkoniumChloride0.1%
.....................................................................AntibacterialDirections
•Wethandsandforearms
•Applyenoughproducttoadequatelycovertheenliresurfacesofthehandsandforearms
•Scrublhoroughlyforatleast30seconds(incluefingernailsandculicles)
•Rinse
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BIOSILK
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73740-4040 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM (UNII: 7N6JUD5X6Y) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) 0.011 g in 100 g WATER (UNII: 059QF0KO0R) 88.5419 g in 100 g ANHYDROMETHYLENECITRIC ACID (UNII: 99197U4E9K) 0.001 g in 100 g LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.1755 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 1.5 g in 100 g FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.0915 g in 100 g ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 g in 100 g SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.5 g in 100 g ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) 0.084 g in 100 g SILK, ACID HYDROLYZED (1000 MW) (UNII: 8549W658QV) 0.0011 g in 100 g PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.4 g in 100 g CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.4 g in 100 g CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) 0.2 g in 100 g POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1 g in 100 g HEXYLENE GLYCOL (UNII: KEH0A3F75J) 0.05 g in 100 g CITRAL (UNII: T7EU0O9VPP) 0.033 g in 100 g COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 3.5 g in 100 g SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) 4 g in 100 g DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E) 0.3 g in 100 g MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) 0.01 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73740-4040-6 163 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/31/2020 2 NDC:73740-4040-1 340 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/31/2020 3 NDC:73740-4040-5 739 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/31/2020 Labeler - Farouk Systems, Inc. (137598132) Registrant - Faoruk Systems, Inc. (137598132) Establishment Name Address ID/FEI Business Operations Farouk Systems, Inc. 137598132 manufacture(73740-4040)