FDA.reportPublic FDA data

TopCare

Manufacturer
TopCo Associates LLC | Apollo Health and Beauty Care Inc.
Effective date
2017-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:46

Label at a glance#

ProductTopCare Antibacterial Foaming Hand Fresh Pear
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

helps eliminate bacteria on the skin.

Dosage and administration

Use only to refill a foaming hand soap pump bottle. From pump bottle, apply onto dry hands work into a lather and rinse thoroughly.

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Uses

INDICATIONS & USAGE SECTION

helps eliminate bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop using this product and ask a doctor if

OTC - STOP USE SECTION

irritation or redness develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Cneter immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Use only to refill a foaming hand soap pump bottle. From pump bottle, apply onto dry hands work into a lather and rinse thoroughly.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 10 (CI 47005), Green 3 (CI 42053).

Label Copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the labelImage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-109-072020-01-31C16284748780-19d75b9d0-831d-f424-e053-dadaa90a57ceDrug Facts
36800-109-332020-01-31C16284748780-19d75b9d0-831d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-109-07TopCareAntibacterial Foaming Hand Fresh Pear222 mL in 1 BOTTLE, PLASTICLIQUID2221
36800-109-33TopCareAntibacterial Foaming Hand Fresh Pear946 mL in 1 BOTTLE, PLASTICLIQUID9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-109TOPCARE ANTIBACTERIAL FOAMING HAND FRESH PEAR (BENZALKONIUM CHLORIDE) LIQUID [TOPCO ASSOCIATES LLC]1Legacy NDC, 2 package rows20170502_b4a7e0b7-47d4-4ed0-a1c5-6c3e9dce3fa2.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-10936800-109-33, 36800-109-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
POLYSORBATE 207T1F30V5YHIACT
GLYCERINPDC6A3C0OXIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%)X70SE62ZARIACT
ALOE VERA LEAFZY81Z83H0XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C GREEN NO. 33P3ONR6O1SIACT

Source Document#

Source XML

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
43a41735-f752-4e70-ad06-b89d019bb5e7b4a7e0b7-47d4-4ed0-a1c5-6c3e9dce3fa22017-05-01WarningsExact identifier
spl id: 43a41735-f752-4e70-ad06-b89d019bb5e7
spl set id: b4a7e0b7-47d4-4ed0-a1c5-6c3e9dce3fa2

Reported adverse events (FAERS/openFDA)#

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