FAIR AND SQUARE ANTIBACTERIAL WITH MOISTURIZERS - benzalkonium chloride solution
Davion, 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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Antibacterial Hand Soap

Drug Facts

Active Ingredients

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Uses

for handwashing to decrease bacteria on the skin

Warnings

For external use only.

Stop use and ask a doctor if irritation or redness develops.

When using this product do not get into eyes. If contact occurs,, rinse eye thoroughly with water.

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

Directions

wet hands
apply palmful to hands
scrub thoroughly
rinse

Inactive ingredients

Water, Cetrimonium Chloride, Glycerin, Lauramidopropyldimethylamine Oxide, Myristamidopropylamine Oxide, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Fragrance, Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (Cl 16035), Yellow 5 (Cl 19140), Red 33 (CI 17200).

* This product is not manufactured or distributed by Colgate Palmolive Company, distributor of Soft Soap®.

Package Label

FAIR & SQUARE ™
ANTIBACTERIAL
HAND
SOAP with
MOISTURIZERS
Compare to Soft Soap®
7.5 FL OZ (221.8 mL)

Label

FAIR AND SQUARE ANTIBACTERIAL WITH MOISTURIZERS
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42669-008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 g in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
GLYCERIN (UNII: PDC6A3C0OX)
LAURAMIDOPROPYL DIMETHYLAMINE (UNII: FS588RR72J)
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFATE (UNII: 0YPR65R21J)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42669-008-08	222 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2013	12/18/2016
2	NDC:42669-008-56	1650 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/18/2013	12/18/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/18/2013	12/18/2016

Labeler - Davion, Inc (174542928)

Revised: 12/2017

Document Id: 29588e47-c045-466a-9b53-ed9011e26426

Set id: 97f7b7c6-a1c3-4899-a07f-5cc07dbab1b1

Version: 2

Effective Time: 20171219

Davion, Inc