PROBLEND ANTIBACTERIAL FOAMING SILK- benzalkonium chloride soap 
Seatex LLC

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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27101 Problend

Active Ingredient Purpose

Benzalkonium Chloride 0.13%............Antibacterial

Uses

For hand washing to decrease bacteria on the skin.

Warnings For external use only.

When using this product Avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops. or if condition persists for more than 72 hours.

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

Directions

Pump into hands, wet as needed.

Lather vigorously for at least 15 seconds.

Wash skin, rinse thoroughly and dry.

Inactive Ingredients

Water, Laurtrimonium Chloride, Alkyl Polyglucoside, Citric Acid, Dye, Fragrance.

Antiseptic, Hand Sanitizer

Front label1.25 L 76250-101-25

back label1.25 L 76250-101-25

55 G 76250-101-5555 G 76250-101-55

275 G 76250-101-75275 G 76250-101-75

330 G 76250-101-33330 G 76250-101-33

PROBLEND ANTIBACTERIAL FOAMING SILK 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76250-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76250-101-251250 g in 1 CARTRIDGE; Type 0: Not a Combination Product08/19/2021
2NDC:76250-101-55206440 g in 1 DRUM; Type 0: Not a Combination Product09/15/2021
3NDC:76250-101-751032202 g in 1 CONTAINER; Type 0: Not a Combination Product09/15/2021
4NDC:76250-101-331249186 g in 1 CONTAINER; Type 0: Not a Combination Product09/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/19/2021
Labeler - Seatex LLC (026647404)
Registrant - Seatex LLC (026647404)
Establishment
NameAddressID/FEIBusiness Operations
Seatex LLC026647404label(76250-101) , manufacture(76250-101) , pack(76250-101)

Revised: 9/2022
Document Id: e90f4c08-0de9-f73e-e053-2a95a90a7faa
Set id: c9f132dd-9f02-d992-e053-2a95a90ade7a
Version: 7
Effective Time: 20220919
 
Seatex LLC