TOPCARE AMBER ANTIBACTERIAL HAND- benzalkonium chloride soap 
Abaco Partners LLC DBA Surefil

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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TopCare ® Amber Antibacterial Hand Soap

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

for hand washing, reduces germs on skin

Warnings

For external use only–hands only

When using this product

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

Stop use and ask a doctor if irritation and redness develops.

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

Directions

Other information

store at 20°C - 25°C (68°F - 77°F)

Inactive Ingredients

Purified Water, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Fragrance, Citric Acid, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Red #4, FD&C Yellow #5.

QUESTIONS?

1-888-423-0139

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label

TopCare®

TRICLOSAN FREE

ANTIBACTERIAL

hand
soap

AMBER

7.5 FL OZ
(221 mL)

PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label
TOPCARE AMBER ANTIBACTERIAL HAND 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20890-0050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColororangeScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20890-0050-1221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/15/2014
2NDC:20890-0050-21180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/201407/08/2019
3NDC:20890-0050-31650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/15/2014
Labeler - Abaco Partners LLC DBA Surefil (964809417)
Establishment
NameAddressID/FEIBusiness Operations
Abaco Partners LLC DBA Surefil964809417manufacture(20890-0050)

Revised: 12/2021
Document Id: d428c448-6e4a-1e4f-e053-2a95a90a1f2a
Set id: f014705d-0584-40d4-a68f-99e9075af64a
Version: 3
Effective Time: 20211227
 
Abaco Partners LLC DBA Surefil