FDA.reportPublic FDA data

AZZURX

Manufacturer
Outbreaks, Inc.
Effective date
2025-01-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:31:28

Label at a glance#

ProductAZZURX
Active ingredientMELISSA OFFICINALIS LEAF, THUJA OCCIDENTALIS LEAF, GERANIUM MACULATUM ROOT, CALENDULA OFFICINALIS FLOWER
Label structure8 sections

Indications and uses

For treatment of cold sores and fever blisters.

Dosage and administration

Application instructions Remove and reverse cardboard sleeve on applicator to expose swab. Crush applicator to activate by squeezing on the “X” (in AZZURX) between thumb and forefinger until you hear a snap. Rotate applicator with swab pointing downward and squeeze gently until the swab is saturated. Discard after use. At the first sign of cold sore/fever blister (tingle) : Clean the area of the tingle before appl...

Label contents#

Full prescribing information#

Active ingredients                              Purpose

OTC - ACTIVE INGREDIENT SECTION

Lemon Balm 3X HPUS                      Antiviral

White Cedar 3X HPUS                      Anti-itch, Pain Reliever

Spotted Geranium 3X HPUS             Antiseptic

Pot Marigold 3X HPUS                     Healing

Uses

INDICATIONS & USAGE SECTION

For treatment of cold sores and fever blisters.

Warnings

WARNINGS SECTION

For external use only.
Flammable, keep away from fire or flame.

Do not use

  • if you are allergic to any ingredient in this product
  • over large areas of the body

When using this product

  • apply only to affected area
  • do not use in or near eyes
  • avoid applying directly inside the mouth
  • you may feel a brief burning sensation when you apply it. It should go away in a short time.
  • do not share or reuse an applicator, as spreading or reinfection may occur.
  •  do not remove cardboard sleeve after crushing,as cuts from glass may occur.

Stop use and ask a doctor if – the cold sore worsens or the cold sore lasts for more than 7 days,

or condition clears up  and occurs again within a few days

Ask a doctor if – you are pregnant or nursing

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

Directions

DOSAGE & ADMINISTRATION SECTION

Application instructions

  • Remove and reverse cardboard sleeve on applicator to expose swab.
  • Crush applicator to activate by squeezing on the “X” (in AZZURX) between thumb and forefinger until you hear a snap.
  • Rotate applicator with swab pointing downward and squeeze gently until the swab is saturated.
  • Discard after use.

At the first sign of cold sore/fever blister (tingle):

  • Clean the area of the tingle before applying.
  • Apply directly to face or lips at the site of the tingle.
  • Repeat every 12 hours until all applicators are used.

After cold sore/fever blister erupts (skin broken):

  • Clean the area of the outbreak before applying.
  • Apply directly to the affected area of the face or lips.
  • Repeat every 24 hours as needed

Children under 12: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Store in a cool dry place away from sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Fractionated coconut oil, essential oil blend of chamomile, lavender, eucalyptus, and peppermint

Questions or Comments?

SPL UNCLASSIFIED SECTION

Call 833-373-4020 or visit azzurx.com

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83243-001-01AZZURX3 in 1 PACKAGELIQUID33
83243-001-01AZZURX0.5 mL in 1 APPLICATORLIQUID0.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83243-001AZZURX (MELISSA OFFICINALIS LEAF,THUJA OCCIDENTALIS LEAF,GERANIUM MACULATUM,CALENDULA OFFICINALLS) LIQUID [OUTBREAKS, INC.]3Current NDC, 2 package rows20250116_9e48aaac-48c2-451d-9f6f-369e65c1c52b.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83243-00183243-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
LAVENDER OILZBP1YXW0H8IACT
EUCALYPTUS OIL2R04ONI662IACT
PEPPERMINT OILAV092KU4JHIACT
MELISSA OFFICINALIS LEAF50D2ZE9219ACTIB
THUJA OCCIDENTALIS LEAF0T0DQN8786ACTIB
GERANIUM MACULATUM ROOT93IXI5B6OJACTIB
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDACTIB

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
AZZURXMELISSA OFFICINALIS LEAF,THUJA OCCIDENTALIS LEAF,GERANIUM MACULATUM,CALENDULA OFFICINALLSOutbreaks, Inc.9e48aaac-48c2-451d-9f6f-369e65c1c52b2025-01-14WarningsExact identifier
ndc (package): 83243-001-01
ndc (product): 83243-001
ndc11 (package): 83243000101
spl id: 29f05aaf-89b2-e293-e063-6394a90ad0e5
spl set id: 9e48aaac-48c2-451d-9f6f-369e65c1c52b

Reported adverse events (FAERS/openFDA)#

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