FLOWER PELLE BUBBLE ANTIBACTERIAL HAND WASH- benzalkonium chloride liquid

Flower Pelle Bubble Antibacterial Hand Wash by

Drug Labeling and Warnings

Flower Pelle Bubble Antibacterial Hand Wash by is a Otc medication manufactured, distributed, or labeled by F&I. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.05%

Purpose

Antimicrobial

Use

• For hand sanitizer to decrease bacteria on the skin

Warnings

For external use only

When using this product, do not use in or near the eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

Pump into hands, wet as needed.
Lather vigorously for at least 10 seconds.
Wash hands, rinse thoroughly and dry

Inactive ingredients

Water, Sodium Laureth Sulfate, Glycerin, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Cocamide MIPA, Sodium Chloride, Fragrance, Citric acid, Butylene Glycol, Hexylene glycol, Isopropanolamine, 1,2-Hexanediol, Portulaca Oleracea Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLOWER PELLE BUBBLE ANTIBACTERIAL HAND WASH 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81328-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ISOPROPANOLAMINE (UNII: UE40BY1BZW)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PURSLANE (UNII: M6S840WXG5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81328-001-02	1 in 1 CARTON	12/22/2020
1	NDC: 81328-001-01	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/22/2020

Labeler - F&I (695504442)

Registrant - F&I (695504442)

Establishment
Name	Address	ID/FEI	Business Operations
F&I		695504442	manufacture(81328-001)