FDA.reportPublic FDA data

Kitchen Lemon Zest Antibacterial Foaming Hand

Manufacturer
Apollo Health and Beauty Care Inc.
Effective date
2019-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:07

Label at a glance#

ProductKitchen Lemon Zest Antibacterial Foaming Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

for washing to decrease bacteria on the skin.

Dosage and administration

apply onto dry hands 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

for washing to decrease 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 use and ask a doctor if

OTC - STOP USE SECTION

irritation ad redness develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestiong, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply onto dry hands
  • lather and rinse thoroughly

Other information

STORAGE AND HANDLING SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Cocamidopropyl Betaine, Glycerin, Hydroxyethylcellulose, Polyquaternium-7, Benzophenone-4, Tetrasodium EDTA, Fragrance (Parfum), Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (CI 19140), Red 40 (CI 16035).

Questions or comments?

OTC - QUESTIONS SECTION

1-866-695-3030

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
63148-016-122021-01-29C16284748780-1ba0f9c33-32fd-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-016-12Kitchen Lemon Zest Antibacterial Foaming Hand355 mL in 1 BOTTLE, PLASTICSOAP3551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-016KITCHEN LEMON ZEST ANTIBACTERIAL FOAMING HAND (BENZALKONIUM CHLORIDE) SOAP [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 1 package rows20190822_2bf01fcc-04ba-4e20-b70a-bc3906d5d781.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-01663148-016-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%)X70SE62ZARIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
SULISOBENZONE1W6L629B4KIACT
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C RED NO. 40WZB9127XOAIACT

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
e83e098d-84ed-45a4-b309-a7dd7faeaaa02bf01fcc-04ba-4e20-b70a-bc3906d5d7812019-08-21WarningsExact identifier
spl id: e83e098d-84ed-45a4-b309-a7dd7faeaaa0
spl set id: 2bf01fcc-04ba-4e20-b70a-bc3906d5d781

Reported adverse events (FAERS/openFDA)#

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