Cobroxin
FDA Label NDC 47219-104

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 Cobroxin (NDC 47219-104). 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:, otc - when using, otc - do not use, directions for use:, other information:, 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 5X

According to the Homeopathic Pharmacopeia of the United States

Purpose

Analgesic

Indications & Usage

Uses: Temporarily relieves joint pain associated with overuse and pain associated with arthritis.

Warnings:

  • -For external use only.
  • -If symptoms persist or worsen, discontinue use and seek medical attention.

Otc - When Using

  • -Avoid contact with eyes. If product gets into eyes, flush with water. Seek Medical attention.

Otc - Do Not Use

  • -Not for use on open wounds.

Directions For Use:

  • Remove protective wrapping.
  • Press down on one side of top to open. Squeeze a small amount of gel into palm and rub vigorously into joints.
  • Use 3-4 times per day for the 1st week. Use as needed thereafter to relieve discomfort.
  • Allow several days for drug to take maximum effect.

Other Information:

  • Do not use if container seal is broken prior to opening.
  • This product is intended for use in cases of recurring joint pain.
  • This product is NOT intended to treat disease. It provides a temporary level of comfort, relief, and a feeling of wellness.
  • This product has been determined to be safe and effective for mild to moderate (Stage 2) chronic pain, as indicated by the Homeopathic Pharmacopeia of the United States.

Other

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

Inactive Ingredients:

Benzalkonium chloride, Methocel, Ethanol, Propylene glycol, Saline

Package Label.Principal Display Panel

Package Label - Principal Display Panel – 1.0 oz Gel Label

1.0 Oz Gel Bottle Label (Cobroxin Figure 1)

1.0 Oz Gel Bottle Label (Cobroxin Figure 1)

Package Label - Principal Display Panel – 1.0 oz Gel Carton

1.0 Oz Gel Bottle Carton (Cobroxin Figure 2)

1.0 Oz Gel Bottle Carton (Cobroxin Figure 2)

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