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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Bath & Beauty Antibacterial Liquid Hand Soap

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

Stop use and ask a doctor if

Keep out of reach of children

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

Directions

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

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

methylchloroisothiazolinone , methlisothiazolinone, Orange (CI 15985).

Adverse Reactions

TSM BRANDS LLC

540 Equinox Ln Manlapan, NJ 07726

Made in TURKEY.

principal display panel

bath

BATHCLEAN

b2b1

ANTIBACTERIAL 
benzalkonium chloride 0.13% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76772-010-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
2NDC:76772-010-68680 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
3NDC:76772-010-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
4NDC:76772-010-33333 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/10/2020
Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
Establishment
NameAddressID/FEIBusiness Operations
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI533120570manufacture(76772-010)

Revised: 9/2020
Document Id: af8b2ea1-92eb-7d92-e053-2995a90af46a
Set id: fd67f205-c2f6-486c-95d8-57c36a6d2a91
Version: 4
Effective Time: 20200917
 
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI