Label: BIOSILK GARDENIA- benzalkonium chloride lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 73740-5001-1 - 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 August 24, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
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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
- Directions
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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
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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
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INGREDIENTS AND APPEARANCE
BIOSILK GARDENIA
benzalkonium chloride lotionProduct 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)