FDA.reportPublic FDA data

Aroma Guru Antibacterial

Manufacturer
GURUNANDA LLC
Effective date
2022-08-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:54:39

Label at a glance#

ProductAroma Guru Antibacterial Toasted Vanilla
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.3%

PRODUCT LABELPRODUCT LABEL

OTC - PURPOSE SECTION

Antibacterial

WARNINGS SECTION

For External Use Only

OTC - WHEN USING SECTION

When using this product- Avoid contact with eyes. In case of eye contact, flush with water.

OTC - STOP USE SECTION

Stop Use and ask Doctor if irritation or 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.

DOSAGE & ADMINISTRATION SECTION

Pump in hands , wet as needed- Lather vigorously for at least 15 seconds- Wash skin thoroughly and dry.

OTHER SAFETY INFORMATION

Store below 110° F (43° C)

INACTIVE INGREDIENT SECTION

Water, Cocamidopropyl Betaine, Glycerin, Decyl Glucoside, Sodium Lauroamphoacetate, Phenoxyethanol, Fragrance, DMDM Hydantoin, Disodium EDTA, Benzophenone-4, Citric Acid, CI 19140

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRODUCT DISPLAYPRODUCT DISPLAY

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70708-063-012025-09-22C16284748780-11030e365-592e-111a-e063-dadaa90a10e2Antibacterial Foaming Hand Soap Toasted Vanilla
70708-063-012024-01-30C16284748780-11030e365-592e-111a-e063-dadaa90a10e2Antibacterial Foaming Hand Soap Toasted Vanilla

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70708-063AROMA GURU ANTIBACTERIAL TOASTED VANILLA (ANTIBACTERIAL HAND SOAP) LIQUID [GURUNANDA LLC]3Legacy NDC20220902_b0cd6841-5e91-6320-e053-2a95a90add09.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70708-06370708-063-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
3f68fbef-b7cb-6e29-e063-6294a90ab0e4b0cd6841-5e91-6320-e053-2a95a90add092025-09-22WarningsExact identifier
spl set id: b0cd6841-5e91-6320-e053-2a95a90add09

Reported adverse events (FAERS/openFDA)#

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