ANTIBACTERIAL- benzalkonium chloride 0.13% liquid
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI

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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Luxury Hygiene Antibacterial Liquid Hand Soap - Lemon

Active ingredients

Benzalkonium chloride 0.13%.................Anitbacterial Hand soap

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

Warnings

For external use only: hands only

When using this product

avoid contact with eyes. If contact occurs, rinse eyes with water

Stop use and ask a doctor if

irritation or redness develops
condition persists for more than 72 hours

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 toroughly

inactive ingredientsc

water, sodium laureth sulfate , cocamidopropyl betaine, sodium chloride, glycerin,

fragrance, polyquatemium-10 , PEG-8 , cidric acid, tetrasodium EDTA, cocamidopropyl pg-dimonium chrolide,

methylchloroisothiazolinone , methlisothiazolinone, blue 1, red 33

Adverse Reactions

TSM BRANDS LLC

540 Equinox Ln Manlapan, NJ 07726

Made in TURKEY.

principal display panel

Untitled

ANTIBACTERIAL
benzalkonium chloride 0.13% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76772-004
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 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
EDETIC ACID (UNII: 9G34HU7RV0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76772-004-80	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/15/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/15/2015

Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)