MANOLIA ANTIBACTERIAL HANDSOAP- benzalkonium chloride liquid
TELLINI INC.

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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MANOLIA ANTIBACTERIAL HAND SOAP WITH MOISTURIZERS

USE

For hand washing to decrease bacteria on the skin. Recommended for repeated use

WARNINGS

For external use only

When using the product; avoid contact with eyes, In case of eye contact, flush with water.

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

DIRECTIONS

Pump into hands and wet as needed. Lather vigorously for at least 15 seconds. Wash skin, rinse thoroughly and dry.

Active Ingredient(s)

Benzalkonium Chloride 0.1% Purpose Antiseptic

Inactive Ingredients

Aqua, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Cocamidopropyl Betain, Styrene/acrylates copolymer, Parfum, Glycerin, Polyquternium-7, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Citcic Acid, Benzophenone-4, Cl42090, Cl 19140

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Purpose

Antiseptic

Package Label - Principal Display Panel

PACKAGE 400 ML Ndc : 80887-005-01

MANOLIA ANTIBACTERIAL HANDSOAP
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80887-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
COCAMIDE (UNII: 3YXD33R71G)	1 g in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 g in 100 mL
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)	1 g in 100 mL
CITRIC ACID ACETATE (UNII: DSO12WL7AU)	1 g in 100 mL
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)	1 g in 100 mL
BENZOPHENONE-5 (UNII: 853Z42ZYAS)	1 g in 100 mL
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)	1 g in 100 mL
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	1 g in 100 mL
WATER (UNII: 059QF0KO0R)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	1 g in 100 mL
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)	1 g in 100 mL
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)	1 g in 100 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	1 g in 100 mL
CHLORINE (UNII: 4R7X1O2820)	1 g in 100 mL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80887-005-01	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/01/2020

Labeler - TELLINI INC. (117014846)

Registrant - TELLINI INC. (117014846)

Name	Address	ID/FEI	Business Operations
Establishment
BSK GRUP KIMYA SANAYI VE TICARET LIMITED SIRKETI		595676471	manufacture(80887-005)