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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Top Care Antibacterial Liquid Hand Soap - With Moisturizer

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

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

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

methylchloroisothiazolinone, methlisothiazolinone, Yellow (CI 19140),Red 33

Principal display panel

ANTIBACTERIAL
benzalkonium chloride 0.13% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76772-033
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)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76772-033-50	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/16/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/16/2021

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

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

Name	Address	ID/FEI	Business Operations
Establishment
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI		533120570	manufacture(76772-033)