BIOSILK GARDENIA- benzalkonium chloride lotion 
Farouk Systems, Inc.

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.

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Biosilk HC Antibacterial Lotion with Gardenia

Active Ingredient

BSCCSLG12 Biosilk H+C Shield Lotion Gardenia-8-21-20Benzalkonium Chloride 0.13%................................Antimicrobial

Warnings

Warnings
For external use only.
When using this product
avoid contact with 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.

80-BSHCSL-Biosilk H+C Shield Lotion Gardenia 12oz-8-18-20

Uses

Use[s] to help reduce bacteria on the skin
recommended for routine use

80-BSHCSL-Biosilk H+C Shield Lotion Gardenia 12oz-8-18-20

Directions

Directions
apply a small amount to palm and rub hands together thoroughly

80-BSHCSL-Biosilk H+C Shield Lotion Gardenia 12oz-8-18-20

Inactive Ingredients

Inactive ingredients: Aqua/Water/Eau, Cetyl Alcohol,
Dimethicone, Propanediol, Cetearyl Alcohol, C15-19 Alkane,
Glycerin, Glyceryl Stearate SE, Ceteareth-20, Caprylyl Glycol,
Aloe Barbadensis Leaf Juice, Hydrolyzed Silk, Hexylene
Glycol, Dimethiconol, Butyrospermum Parkii (Shea) Butter,
Pentylene Glycol, Ethylhexylglycerin, Disodium EDTA,
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium
Hydroxide, Alcohol Denat., Fragrance (Parfum), Benzyl
Benzoate, Benzyl Salicylate, Eugenol, Hydroxycitronellal

BSHCSLG12 Biosilk H+C Shield Lotion Gardenia-08-21-20

Warnings

Keep out of reach of children. In case of accidental ingestion,
get medical help or contact a Poison Control Center immediately.

BSHCSLG12 Biosilk H+C Shield Lotion Gardenia-08-21-20

Warnings

Warnings
For external use only.
When using this product
avoid contact with 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
apply a small amount to palm and rub hands together thoroughly

BSHCSLG12 Biosilk H+C Shield Lotion Gardenia-08-21-20

BioSilk Health + Care

Biosilk Health +Care Antibacterial Shield Lotion with Aloe Vera, Gardenia & Silk

95% Natural

Paraben Free

Kills 99.9% of germs

FDA Registration # NDC 73740-5001-1

pH 5.5

MADE IN THE USA

12 flo oz (355 ml)

80-BSHCSL-Biosilk H+C Shield Lotion Gardenia 12oz-8-18-20

BIOSILK GARDENIA 
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73740-5001
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL BENZOATE (UNII: N863NB338G) 0.1554 g  in 100 g
BENZYL SALICYLATE (UNII: WAO5MNK9TU) 0.00123 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 g  in 100 g
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) 0.36 g  in 100 g
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.2 g  in 100 g
PROPANEDIOL (UNII: 5965N8W85T) 2.1 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 2 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) 0.013 g  in 100 g
EUGENOL (UNII: 3T8H1794QW) 0.00129 g  in 100 g
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) 0.00141 g  in 100 g
DIMETHICONE 100 (UNII: RO266O364U) 3.64 g  in 100 g
C15-19 ALKANE (UNII: CI87N1IM01) 2 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 1.6 g  in 100 g
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.14067 g  in 100 g
WATER (UNII: 059QF0KO0R) 77.8849 g  in 100 g
SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07) 0.001 g  in 100 g
CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1 g  in 100 g
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU) 0.3 g  in 100 g
PENTYLENE GLYCOL (UNII: 50C1307PZG) 0.3 g  in 100 g
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.15 g  in 100 g
HEXYLENE GLYCOL (UNII: KEH0A3F75J) 0.4 g  in 100 g
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) 0.1 g  in 100 g
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.02 g  in 100 g
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) 1.6 g  in 100 g
CETYL ALCOHOL (UNII: 936JST6JCN) 3.9 g  in 100 g
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73740-5001-1354.88 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/24/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/24/2020
Labeler - Farouk Systems, Inc. (137598132)
Registrant - Farouk Systems, Inc. (137598132)
Establishment
NameAddressID/FEIBusiness Operations
Farouk Systems, Inc.137598132manufacture(73740-5001)

Revised: 8/2020
Document Id: ada25c9b-4b9f-4b68-e053-2a95a90a8cb2
Set id: ada25c9b-4b9e-4b68-e053-2a95a90a8cb2
Version: 1
Effective Time: 20200824
 
Farouk Systems, Inc.