AZZURX- melissa officinalis leaf,thuja occidentalis leaf,geranium maculatum,calendula officinalls liquid

AZZURX by

Drug Labeling and Warnings

AZZURX by is a Homeopathic medication manufactured, distributed, or labeled by Outbreaks, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                              Purpose

Lemon Balm 3X HPUS                      Antiviral

White Cedar 3X HPUS                      Anti-itch, Pain Reliever

Spotted Geranium 3X HPUS             Antiseptic

Pot Marigold 3X HPUS                     Healing

PURPOSE

Uses

For treatment of cold sores and fever blisters.

Warnings

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.

KEEP OUT OF REACH OF CHILDREN

Directions

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

Store in a cool dry place away from sunlight.

Inactive ingredients

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

Questions or Comments?

Call 833-373-4020 or visit azzurx.com

Product label

INGREDIENTS AND APPEARANCE

AZZURX 
melissa officinalis leaf,thuja occidentalis leaf,geranium maculatum,calendula officinalls liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83243-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) (MELISSA OFFICINALIS LEAF - UNII:50D2ZE9219)	MELISSA OFFICINALIS LEAF	3 [hp_X]  in 0.5 mL
THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (THUJA OCCIDENTALIS LEAF - UNII:0T0DQN8786)	THUJA OCCIDENTALIS LEAF	3 [hp_X]  in 0.5 mL
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ) (GERANIUM MACULATUM ROOT - UNII:93IXI5B6OJ)	GERANIUM MACULATUM ROOT	3 [hp_X]  in 0.5 mL
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	3 [hp_X]  in 0.5 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
LAVENDER OIL (UNII: ZBP1YXW0H8)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83243-001-01	3 in 1 PACKAGE	02/13/2023
1		0.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/13/2023

Labeler - Outbreaks, Inc. (118810120)