TopCare Amber Antibacterial Hand

Manufacturer
Abaco Partners LLC DBA Surefil
Effective date
2021-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:20:48

Label at a glance#

ProductTopCare Amber Antibacterial Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Wash hands and rinse.

Storage and handling

store at 20°C - 25°C (68°F - 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

for hand washing, reduces germs on skin

Warnings

WARNINGS SECTION

For external use only–hands only

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash hands and rinse.

Other information

STORAGE AND HANDLING SECTION

store at 20°C - 25°C (68°F - 77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-888-423-0139

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare®

TRICLOSAN FREE

ANTIBACTERIAL

hand
soap

AMBER

7.5 FL OZ
(221 mL)

PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W71
BenzalkoniumACTIVE MOIETY7N6JUD5X6Y1
Cetrimonium ChlorideINACTIVE INGREDIENTUC9PE95IBP1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP1
Coco MonoethanolamideINACTIVE INGREDIENTC80684146D1
Edetate SodiumINACTIVE INGREDIENTMP1J8420LU1
FD&C Red No. 4INACTIVE INGREDIENTX3W0AM1JLX1
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1M1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Lauramidopropylamine OxideINACTIVE INGREDIENTI6KX160QTV1
MethylChloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPN1
MethylisothiazolinoneINACTIVE INGREDIENT229D0E1QFA1
PEG-120 Methyl Glucose DioleateINACTIVE INGREDIENTYM0K64F20V1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
20890-005020890-0050-1, 20890-0050-2, 20890-0050-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 333 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii candidate
134 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MCONCENTRATE / BUCCALNAExact identifier — unii candidate
22 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR45 mgExact identifier — unii candidate
134 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, CHEWABLE / ORAL4.5 mgExact identifier — unii candidate
22 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / ENDOTRACHEAL68 mgExact identifier — unii candidate
134 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR226 mgExact identifier — unii candidate
134 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / RECTALNAExact identifier — unii candidate
134 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, COATED / ORAL7.93 mgExact identifier — unii candidate
22 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRACARDIAC70 mgExact identifier — unii candidate
134 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
Edetate SodiumEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / IONTOPHORESIS0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / AURICULAR (OTIC)18 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / DENTAL0.4 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO, SUSPENSION / TOPICAL0.25 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR360 mgExact identifier — unii candidate
134 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAMUSCULAR28 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRATUMOR1.2 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
Edetate SodiumEDETATE SODIUMMP1J8420LUSOLUTION / OPHTHALMIC0.1 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MCAPSULE / ORAL652 mgExact identifier — unii candidate
22 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XGEL / VAGINAL10 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / TOPICAL0.32 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, COATED / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
Coco MonoethanolamideCOCO MONOETHANOLAMIDEC80684146DSHAMPOO / TOPICAL4 %w/wExact identifier — unii candidate
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSYRUP / ORAL40 mgExact identifier — unii candidate
134 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET / ORAL231 mgExact identifier — unii candidate
134 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR38 mgExact identifier — unii candidate
88 equally ranked IID candidates
Edetate SodiumEDETATE SODIUMMP1J8420LUTABLET / ORAL5 mgExact identifier — unii candidate
12 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / IRRIGATION1 mgExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAVENOUS2068 mgExact identifier — unii candidate
88 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / OPHTHALMIC10 mgExact identifier — unii candidate
134 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / RETROBULBAR648 mgExact identifier — unii candidate
134 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
134 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET / SUBLINGUAL24 mgExact identifier — unii candidate
88 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR24 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / INTRAMUSCULAR9 mgExact identifier — unii candidate
134 equally ranked IID candidates
FD&C Yellow No. 5FD&C YELLOW NO. 5I753WB2F1MTABLET, FILM COATED / ORAL1.68 mgExact identifier — unii candidate
22 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d428c448-6e4a-1e4f-e053-2a95a90a1f2af014705d-0584-40d4-a68f-99e9075af64a2021-12-27WarningsExact identifier
spl id: d428c448-6e4a-1e4f-e053-2a95a90a1f2a
spl set id: f014705d-0584-40d4-a68f-99e9075af64a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.