BIOSILK GARDENIA- benzalkonium chloride lotion

Biosilk Gardenia by

Drug Labeling and Warnings

Biosilk Gardenia by is a Otc medication manufactured, distributed, or labeled by Farouk Systems, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium 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.

Uses

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

Directions

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

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

Warnings

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

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

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)

INGREDIENTS AND APPEARANCE

BIOSILK GARDENIA 
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73740-5001
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73740-5001-1	354.88 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/24/2020

Labeler - Farouk Systems, Inc. (137598132)

Registrant - Farouk Systems, Inc. (137598132)

Establishment
Name	Address	ID/FEI	Business Operations
Farouk Systems, Inc.		137598132	manufacture(73740-5001)