FDA.reportPublic FDA data

Antibacterial Gold

Manufacturer
Kareway Product, Inc.
Effective date
2020-07-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:22

Label at a glance#

ProductAntibacterial Gold
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Wet bar with water Lather vigorously and wash skin Rinse and dry thoroghly

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

For washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

  • Avoid contact with eyes. In case of eye contact, flush with water.
  • Stop use and ask a doctor if irritation and redness develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet bar with water
  • Lather vigorously and wash skin
  • Rinse and dry thoroghly

Inactive Ingredient

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, etidronate tetrasodium, fragrance, glycerine, orange HO, PEG-6 methyl ether, pentasodium pentetate, sodium chloride, sodium laureth-5 sulfate, sodium palm kernelate, sodium palmate, sorbitol, titanium dioxide, water

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1926450benzalkonium chloride 0.1 % Medicated Bar SoapPSN1
1926450benzalkonium chloride 0.001 MG/MG Medicated Bar SoapSCD1
1926450benzalkonium chloride 0.1 % Medicated Bar SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67510-0116-32022-01-28C16284748780-1d6a99b39-91e9-a426-e053-dadaa90af4c2Pure-Aid Antibacterial Soap Gold

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0116-3Antibacterial Gold100 g in 1 BOXSOAP1001
67510-0116-3Antibacterial Gold3 in 1 CELLO PACKSOAP31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0116ANTIBACTERIAL GOLD (BENZALKONIUM CHLORIDE) SOAP [KAREWAY PRODUCT, INC.]1Legacy NDC, 2 package rows20200724_ab0c9f34-c8b2-a268-e053-2995a90a271e.zip

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
67510-011667510-0116-3

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PALMITIC ACID2V16EO95H1IACT
PEG-6 METHYL ETHERWXH089JZ5EIACT
PENTASODIUM PENTETATE961TOZ5L7TIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PALMITATEJQ43KP6296IACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
SORBITOL506T60A25RIACT
ETIDRONATE TETRASODIUMCZZ9T1T1X4IACT
WATER059QF0KO0RIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

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
ab0c998c-ab50-a258-e053-2995a90aaf8cab0c9f34-c8b2-a268-e053-2995a90a271e2020-07-22WarningsExact identifier
spl id: ab0c998c-ab50-a258-e053-2995a90aaf8c
spl set id: ab0c9f34-c8b2-a268-e053-2995a90a271e

Reported adverse events (FAERS/openFDA)#

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