FDA Label for Azzurx

View Indications, Usage & Precautions

Azzurx Product Label

The following document was submitted to the FDA by the labeler of this product Outbreaks, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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.


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




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