FLOWER PELLE BUBBLE ANTIBACTERIAL HAND WASH- benzalkonium chloride liquid 
F&I

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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81328-001_Flower Pelle Bubble Antibacterial Hand Wash

Active ingredient

Benzalkonium Chloride 0.05%

Purpose

Antimicrobial

Use

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

Product Label

FLOWER PELLE BUBBLE ANTIBACTERIAL HAND WASH 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81328-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81328-001-021 in 1 CARTON12/22/2020
1NDC:81328-001-01250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/22/2020
Labeler - F&I (695504442)
Registrant - F&I (695504442)
Establishment
NameAddressID/FEIBusiness Operations
F&I695504442manufacture(81328-001)

Revised: 12/2020
Document Id: b70aa944-47da-475b-e053-2a95a90ae804
Set id: 8b8aadf3-2be7-4c3e-97a6-3fc660fe0d75
Version: 1
Effective Time: 20201222
 
F&I