FDA.reportPublic FDA data

Curoxen Oral Care

Manufacturer
OrganiCare Nature's Science, LLC
Effective date
2025-10-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:37:08

Label at a glance#

ProductCuroxen Oral Care
Active ingredientCLOVE OIL, OLEA EUROPAEA FRUIT VOLATILE OIL, CALENDULA OFFICINALIS FLOWERING TOP
Label structure13 sections

Storage and handling

Other information store at 68° to 77°F (20° to 25°C) if liquefied, refrigerate 10 minutes to thicken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Calendula 3X HPUS

Clove essential oil 1X

Olive extract 2X HPUS

OTC - PURPOSE SECTION

Purposes

Healing agent

Oral pain reliever

Oral antimicrobial and healing agent

INDICATIONS & USAGE SECTION

Uses

for the temporary relief of pain and to help prevent infection and promote healing of:

  • canker sores
  • cold sores
  • fever blisters
  • minor irritation, injury, cuts or other sores of the mouth and gums.

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • sore mouth symptoms do not improve in 7 days
  • swelling, rash, fever or other allergic reaction develops
  • irritation, pain or redness persists or worsens

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If excessive product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children of any age, apply to the affected area as needed
  • Children under 12 years of age should be supervised in the use of this product

STORAGE AND HANDLING SECTION

Other information

  • store at 68° to 77°F (20° to 25°C)
  • if liquefied, refrigerate 10 minutes to thicken

INACTIVE INGREDIENT SECTION

Inactive ingredients

oxygenated olive oil, pure essential oil (cinnamon)

OTC - QUESTIONS SECTION

Questions?

Call 512-401-3572 or visit www.curoxen.com

SPL UNCLASSIFIED SECTION

Made in Italy

Distributed by OrganiCare®, Austin, TX 78744

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MADE WITH ORGANIC INGREDIENTS

NO Artificial Drugs or Chemicals

#1 Oral Germ Killer

Instant Pain Relief

CUROXEN® ORAL CARE

A Homeopathic Medicine that provides pain relief, speeds healing, and helps prevent Infection in mouth sores

Pain relief and treatment of:

  • Canker sores
  • Cheek bites
  • Cold sores, and abrasions from braces & dentures

Mouth Sore Treatment

  • Pain Relief
  • Healing
  • Fights Infection

NET WT 0.42 oz (11.9 g)

Curoxen Oral RevisedCuroxen Oral Revised

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71042-004-12Curoxen Oral Care1 in 1 CARTONOINTMENT17
71042-004-12Curoxen Oral Care12 g in 1 TUBEOINTMENT127

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71042-00471042-004-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CINNAMON OILE5GY4I6YCZIACT
OLIVE OIL6UYK2W1W1EIACT
CLOVE OIL578389D6D0ACTIB
OLEA EUROPAEA FRUIT VOLATILE OIL8E7358CX1JACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-12-12full-release2026-06-01 02:29:36

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
Curoxen Oral CareOLIVE EXTRACT, CALENDULA, CLOVE OILOrganiCare Nature's Science, LLC60cc114f-f63b-60f6-e053-2a91aa0acd532025-10-20WarningsExact identifier
ndc (package): 71042-004-12
ndc (product): 71042-004
ndc11 (package): 71042000412
spl id: 419b403c-ddbf-7e14-e063-6394a90a1a90
spl set id: 60cc114f-f63b-60f6-e053-2a91aa0acd53

Reported adverse events (FAERS/openFDA)#

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