SCENT THEORY - SCENTFULL FOAMING HAND SANITIZER - 0.1% BKC (76891-201), DELIST

SCENTFULL FOAMING HAND SANITIZER by

Drug Labeling and Warnings

SCENTFULL FOAMING HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by SCENT THEORY PRODUCTS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SCENTFULL FOAMING HAND SANITIZER- benzalkonium chloride solution 
SCENT THEORY PRODUCTS LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SCENT THEORY - SCENTFULL FOAMING HAND SANITIZER - 0.1% BKC (76891-201), DELIST

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.1%

PURPOSE

ANTISEPTIC

USES

• decreases bacteria on hands

WARNINGS

Use only as directed. For external use only.

When using this product. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation and redness develop or increase.

Keep out of reach of children. If  swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Dispense a palm-sized amount onto hands.

• Rub hands together until dry.

INACTIVE INGREDIENTS

LAVENDAR CHAMOMILE:  Water (Aqua), Glycerin,Fragrance (Parfum), PEG-26-Buteth-26, PEG-40 ydrogenated Castor Oil, Didecyldimonium Chloride, Phenoxyethanol, Polyaminopropyl Biguanide, Citric Acid, Sodium Hyroxide, Lavandula Hybrid Oil, Yellow 5 (CI 19140), Red 33 (CI 17200), Blue 1 (CI 42090).

EUCALYPTUS SPEARMINT: Water (Aqua), Glycerin,Fragrance (Parfum), PEG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Didecyldimonium Chloride, Phenoxyethanol, Polyaminopropyl Biguanide, Citric Acid, Sodium Hyroxide, Eucalyptus globulus leaf oil,Blue 1 (CI 42090),  Yellow 5 (CI 19140)

PINEAPPLE MANGO: Water (Aqua), Glycerin, PEG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Didecyldimonium Chloride, Fragrance (Parfum), Polyaminopropyl Biguanide, Phenoxyethanol, Citric Acid, Sodium Hyroxide, Mangifera indica (mango) seed oil, Red 33 (CI 14700), Yellow 5 (CI 19140)

SUNKISSED LEMON: Water (Aqua), Glycerin, Fragrance (Parfum), PEG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Didecyldimonium Chloride, Phenoxyethanol, Polyaminopropyl Biguanide, Citric Acid, Sodium Hyroxide, Citrus Limon (lemon) peel oil, Yellow (CI 19140), Red 33 (CI 14700)

COCONUT VANILLA: Water (Aqua), Glycerin, PEG-26-Buteth-26, Fragrance (Parfum), PEG-40 Hydrogenated Castor Oil, Didecyldimonium Chloride, Phenoxyethanol, Polyaminopropyl Biguanide, Citric Acid, Sodium Hyroxide, Vanilla panifolia fruit oil,Yellow 5 (CI 19140), Red 33 (CI 14700), Blue 1 (CI 42090)

SCENTFULL FOAMING HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76891-201
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
GLYCERIN (UNII: PDC6A3C0OX)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)
EUCALYPTUS OIL (UNII: 2R04ONI662)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
MANGIFERA INDICA SEED (UNII: EDO6T18WTC)
LAVENDER OIL (UNII: ZBP1YXW0H8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76891-201-11	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2021	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/19/2021	12/31/2021

Labeler - SCENT THEORY PRODUCTS LLC (101216246)

Revised: 1/2022

Document Id: d5a42960-ab14-bdfd-e053-2a95a90a680f

34390-5

Set id: dd71137d-5f78-4035-a9de-3e00214feb25

Version: 5

Effective Time: 20220115