Label: BIOSILK- benzalkonium chloride shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 73740-7070-1 - 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 September 30, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Warnings
Warnings
For external use only.
When using this product
do not use in or near eyes
if contact occurs, rinse eyes thoroughly
with water
Stop use and ask a doctor if
irritation and redness develop
Keep out of reach of children.
In case of accidental ingestion, get
medical help or contact a Poison
Control Center immediately. - Directions
- USE
- Active ingredient
- Stop use and ask a doctor
- Keep out of reach of children
- When using this product
- Purpose
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Inactive Ingredients
Aqua/Water/Eau,
Cocamidopropyl
Betaine,
Cocamidopropyl
Hydroxysultaine,
Glycerin, Glycol
Distearate, Decyl
Glucoside, Aloe
Barbadensis Leaf Juice,
Lavandula Angustifolia
(Lavender) Oil,
Hydrolyzed Silk,
Acrylates Copolymer,
PEG-150 Pentaerythrityl
Tetrastearate, Caprylyl
Glycol,
Polyquaternium-10, PEG-6
Caprylic/Capric Glycerides,
Hexylene Glycol, Disodium
EDTA, Pentylene Glycol,
Ethylhexylglycerin,
Cetrimonium Chloride,
Propanediol, Alcohol Denat.,
Fragrance (Parfum), Benzyl
Benzoate, Butylphenyl
Methylpropional, Coumarin, Linalool - Biosilk H+B Shampoo
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INGREDIENTS AND APPEARANCE
BIOSILK
benzalkonium chloride shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73740-7070 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 PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM) 0.528 g in 100 g POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK) 0.27 g in 100 g PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8) 0.264 g in 100 g HEXYLENE GLYCOL (UNII: KEH0A3F75J) 0.2 g in 100 g FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.355 g in 100 g COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) 4 g in 100 g CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.5 g in 100 g WATER (UNII: 059QF0KO0R) 70.647 g in 100 g ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 g in 100 g PENTYLENE GLYCOL (UNII: 50C1307PZG) 0.15 g in 100 g ALCOHOL (UNII: 3K9958V90M) 0.014 g in 100 g EDETIC ACID (UNII: 9G34HU7RV0) 0.15 g in 100 g BENZYL BENZOATE (UNII: N863NB338G) 0.5 g in 100 g DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 1.5 g in 100 g BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) 0.9 g in 100 g COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 14 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) 3 g in 100 g AMINO ACIDS, SILK (UNII: V0L00EX1IA) 0.011 g in 100 g CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) 0.075 g in 100 g PROPANEDIOL (UNII: 5965N8W85T) 0.05 g in 100 g LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.03 g in 100 g GLYCOL DISTEARATE (UNII: 13W7MDN21W) 2.5 g in 100 g ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 g in 100 g LAVENDER OIL (UNII: ZBP1YXW0H8) 0.01 g in 100 g BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.075 g in 100 g COUMARIN (UNII: A4VZ22K1WT) 0.04 g in 100 g Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73740-7070-1 354.88 g in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/30/2020 Labeler - Farouk Systems, Inc. (137598132) Registrant - Farouk Systems, Inc. (137598132) Establishment Name Address ID/FEI Business Operations Farouk Systems, Inc. 137598132 manufacture(73740-7070)