ANTIBACTERIAL- benzalkonium chloride 0.13% liquid

Antibacterial by

Drug Labeling and Warnings

Antibacterial by is a Otc medication manufactured, distributed, or labeled by TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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

Purpose

Antibacterial Hand Soap

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

• Squeeze onto wet hands or body sponge 
• Work into lather 
• Wash skin,rinse and dry toroughly

INACTIVE INGREDIENT

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

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

methylchloroisothiazolinone , methlisothiazolinone, Green (CI 43090 - 19140)

In case of adverse reaction

TSM BRANDS LLC

540 Equinox Ln Manlapan, NJ 07726

Made in TURKEY.

principal display panel

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL 
benzalkonium chloride 0.13% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76772-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76772-011-03	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/10/2020
2	NDC: 76772-011-68	680 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/10/2020

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

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

Establishment
Name	Address	ID/FEI	Business Operations
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI		533120570	manufacture(76772-011)