Vitynex Topical Homeopathic Calendula Wound Care Cream
FDA Label NDC 84337-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Curapep for the product Vitynex Topical Homeopathic Calendula Wound Care (NDC 84337-001). 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 drug facts, active ingredient, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Calendula officinalis 1X 1% HPUS

The letters "HPUS" indicate that the component in this product is officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Purpose

Healing 

Uses

  • Helps soothe and promote fast healing and repair of skin abrasions, shallow wounds, minor burns, including sunburn, insect bites, and improve surgical scars.
  • Calms skin irritation.

Warnings

For external use only.

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • animal bites
  • serious burns

When Using This Product

  • do not get into eyes.

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or re-occur

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Wash and dry affected skin.
  • Apply an ample amount of cream.
  • Cover with a clean bandage as needed.
  • Repeat procedure 1 to 3 times daily until skin improves or as directed by a doctor.

Other Information

  • Store at room temperature.
  • Do not use if the seal is broken.

Inactive Ingredients

Chaste Tree ( Vitex agnus-castus), Cyclopentasiloxane, Disodium EDTA, Emulsifying Wax NF, Ethylhexyl Stearate, Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Phenoxyethanol, Propylene Glycol, Puerarin, Sorbitol, Tocopheryl Acetate, Water (Aqua).

Package Labeling:

Label (Label)

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