Ocumend
FDA Label NDC 76277-211

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cearna, Inc. for the product Ocumend (NDC 76277-211). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients for Vial:

Arnica Montana 52M 50% HPUS

Ledum Palustre 52M 50% HPUS


Active Ingredients for Healing Gels:

Arnica Montana 52M 50% HPUS

Ledum Palustre 52M 50% HPUS


Otc - Purpose

Purpose for Vial:

Arnica Montana 52M 50% HPUS .................................... Bruising

Ledum Palustre 52M 50% HPUS ..................................Black Eye

Purpose for Healing Gels:

Arnica Montana 52M 50% HPUS .................................... Bruising

Ledum Palustre 52M 50% HPUS ..................................Black Eye

Indications & Usage

Uses for Vial:

For the reduction of bruising, swelling and pain.

Uses for Healing Gels:

For the reduction of bruising, swelling and pain.

Warnings

Warnings for Vial:

For external use only

Warnings for Healing Gels:

For external use only


Otc - Do Not Use

Do not use for Vial:

Do not use

  • in the eyes
  • if solution becomes cloudy
  • if tamper seal is broken
    • Do not use for Healing Gels:

    Do not use

    • in the eyes
    • over open wounds
    • if you have unexpected bleeding

Otc - Stop Use

Stop use for Vial:

Stop use and ask a doctor if condition worsens.

Stop use for Healing Gels:

Stop use and ask a doctor if condition worsens.

Otc - Pregnancy Or Breast Feeding

Pregnancy Warning for Vial:

If pregnant or breast-feeding ask a health professional before use.

Pregnancy Warning for Healing Gels:

If pregnant or breast-feeding ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Children Section for Vial:

Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Children Section for Healing Gels:

Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions for Vial:

Use as directed by a physician.  Pour contents of vial into sterile water.  Soak sterile gauze in water mixture and apply to affected site.

Directions for Healing Gels:

Use as directed by a physician.  Place healing gels on intact skin and replace as needed.

Storage And Handling

Other information for Vial:

Store at room temperature.  Discard 30 days after opening.

Other information for Healing Gels:

Store at room temperature.

Inactive Ingredient

Inactive Ingredients (non-preserved) for Vial:

Citrates, Polysorbate 80, Sodium Chloride, Sterile Water

Inactive Ingredients for Healing Gels:

Acrylates/Acrylamide Co-polymer, Hydroxyethyl Cellulose, Methyldiethanolamine, Water

Description

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.

Do not use if box seal is broken or missing, if peel pouches are open or if band on vial is broken or missing.

Package Label.Principal Display Panel

Ocumend Principal Display Panel (Ocumend1)

Ocumend Principal Display Panel (Ocumend1)


Ocumend Drug Facts (Ocumend2)

Ocumend Drug Facts (Ocumend2)



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