Nyloxin
FDA Label NDC 47219-252

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Receptopharm Inc for the product Nyloxin (NDC 47219-252). 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, indications & usage, warnings:, directions for use:, other information:, other, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Asian Cobra venom 350 mcg/mL

Purpose

Analgesic

According to the Homeopathic Pharmacopeia of the United States

Indications & Usage

Uses: Temporarily relieves pain associated with sore back, inflamed joints, migraines, painful menses, and general presistent pain

Warnings:

  • -Side effects may include headahce, nausea, sore throat, allergic rhinitis and gastointestinal upset.
  • -If symptoms persist or worsen, stop using this product and consult a physician.
  • - When Using This Product: avoid contact with the eyes. If product gets into eyes, flush with water. Seek medical attention.

Directions For Use:

  • Break off protective tab.
  • Turn press lock so spray nozzle is visible in front.
  • Press down 4 x to prime the pump.
  • Spray 2 x directly into mouth or under tongue.
  • Use spray intially every 3-4 hours.

Other Information:

  • Do not use if tamper-proof seal is broken.
  • This product is NOT intended to treat disease, it can provide a temporary level of comfort, relief and a feeling of wellness.
  • This product has been determined to be safe and effective for moderate to severe (Stage 2) pain.
  • Clinical experience suggests Nyloxin may provide relief from other forms of pain.

Other

  • Pregnant or nursing women and children should not use this product unless advised by a physician.

Inactive Ingredients:

Citric Acid, Ethanol, Flavoring, Methylparaben, Sodium Citrate, Xylitol.

Package Label.Principal Display Panel

Package Label - Principal Display Panel – 1.0 oz Spray Label

1.0 Oz Spray Bottle Label (Nyloxin Figure 1)

1.0 Oz Spray Bottle Label (Nyloxin Figure 1)

Package Label - Principal Display Panel – 1.0 oz Spray Carton

1.0 Oz Spray Bottle Carton (Nyloxin Figure 2)

1.0 Oz Spray Bottle Carton (Nyloxin Figure 2)

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