Vitynex Topical Homeopathic Calendula Wound Care Cream

Manufacturer
CuraPep
Effective date
2024-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:27:42

Label at a glance#

ProductVitynex Topical Homeopathic Calendula Wound Care
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure7 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Healing 

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84337-001-00Vitynex Topical Homeopathic Calendula Wound Care28 g in 1 TUBECREAM281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84337-001VITYNEX TOPICAL HOMEOPATHIC CALENDULA WOUND CARE (CALENDULA) CREAM [CURAPEP]11 package rows20240802_ac14be44-8d10-4a09-85e2-2a23cf9e95fd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84337-00184337-001-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1bcba6dc-de00-2501-e063-6394a90a183dac14be44-8d10-4a09-85e2-2a23cf9e95fd2024-06-26WarningsExact identifier
spl id: 1bcba6dc-de00-2501-e063-6394a90a183d
spl set id: ac14be44-8d10-4a09-85e2-2a23cf9e95fd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.