Azzurx Liquid
FDA Label NDC 83243-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Outbreaks, Inc. for the product Azzurx (NDC 83243-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients                              purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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