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Drug Facts
Made in Italy
Distributed by OrganiCare®, Austin, TX 78744
Curoxen Oral Care Ointment
FDA Label NDC 71042-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Organicare Nature's Science, Llc for the product Curoxen Oral Care (NDC 71042-004). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, 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
Calendula 3X HPUS
Clove essential oil 1X
Olive extract 2X HPUS
Otc - Purpose
Purposes
Healing agent
Oral pain reliever
Oral antimicrobial and healing agent
Indications & Usage
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
Warnings
Otc - Stop Use
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
Keep out of reach of children. If excessive product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
Other information
- store at 68° to 77°F (20° to 25°C)
- if liquefied, refrigerate 10 minutes to thicken
Inactive Ingredient
Inactive ingredients
oxygenated olive oil, pure essential oil (cinnamon)
Otc - Questions
Questions?
Call 512-401-3572 or visit www.curoxen.com
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
- Pain Relief
- Healing
- Fights Infection
Mouth Sore Treatment
NET WT 0.42 oz (11.9 g)
* Please review the disclaimer below.
