Indications and uses
Temporarily relieves the symptoms of canker sores, including discomfort of gums or tongue
Canker Sore Relief Rinse
- Manufacturer
- Hyland's | Applied Laboratories, Inc.
- Effective date
- 2019-10-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:58:25
Label at a glance#
ProductCanker Sore Relief Rinse
Active ingredientECHINACEA ANGUSTIFOLIA, SODIUM CHLORIDE, MYRRH, GOLDENSEAL
Label structure7 sections
Dosage and administration
Shake well before using Measure only with the dosing cup provided. Do not use dosing cup with other products. On dosing cup, mL = milliliter. Adults and children 12 years and over Rinse 10 mL around in mouth over affected area for at least one minute, then spit out. Use up to four times daily until relieved. Do not swallow. Children 6 years to under 12 years Use under supervision. Rinse 5 mL around in mouth over a...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients
Echinacea 6X HPUS
Hydrastis 6X HPUS
Myrrha 4X HPUS
Natrum Muriaticum 30X HPUS
"HPUS" indicates that the active ingredients are in the
official Homeopathic Pharmacopoeia of the United States.
Purpose
canker sores
discomfort of gums or tongue due to canker sores
canker sores
discomfort of gums or tongue due to canker sores
Uses
- Temporarily relieves the symptoms of canker sores, including discomfort of gums or tongue
Warnings
As with any drug, ask a doctor before use if pregnant
or breast-feeding.
SPL UNCLASSIFIED SECTION
Do not use more than directed. DO NOT SWALLOW.
SPL UNCLASSIFIED SECTION
Consult a dentist or physician if:
- symptoms persist for more than 7 days or worsen.
- swelling, rash or fever develops.
- irritation, pain or redness persists or worsens.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep this and all medications out of the reach of children.
SPL UNCLASSIFIED SECTION
In case of emergency or if you accidentally swallow more than used for rinsing, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
Directions
- Shake well before using
- Measure only with the dosing cup provided.
- Do not use dosing cup with other products.
- On dosing cup, mL = milliliter.
Adults and children 12 years and over | Rinse 10 mL around in mouth over affected area for at least one minute, then spit out. Use up to four times daily until relieved. Do not swallow. |
Children 6 years to under 12 years | Use under supervision. Rinse 5 mL around in mouth over affected area for at least one minute, then spit out. Use up to four times daily until relieved. Do not swallow. |
Children under 6 years | Consult a dentist or physician. |
Drug Facts (continued)
Other information
- Do not use if imprinted "SEALED FOR YOUR
- PROTECTION" tamper-evident bottle cap band is broken or missing.
- The inner packaged bottle is child-resistant.
- Store at room temperature.
- Do not refrigerate.
Inactive ingredients
Citric Acid, Citrus Extract, Glycerine, Hydroxyethyl Cellulose, Purified Water, Sodium Citrate.
Questions or comments?
(800) 624-9659
SPL UNCLASSIFIED SECTION
* CLAIMS BASED ON TRADITIONAL HOMEOPATHIC
PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE.
NOT FDA EVALUATED.
PRINCIPAL DISPLAY PANEL - 236 mL BOTTLE CARTON
NDC 54973-3405-1
HOMEOPATHIC
NATURAL
RELIEF
SINCE 1903
Hyland's
CANKER
SORE
RELIEF RINSE*
FREE OF BENZOCAINE
& HYDROGEN PEROXIDE
• WITHOUT NUMBING
OR BURNING
• SOOTHES & PROMOTES
HEALING
• FOR MOUTH SORES
& ABRASIONS
8 FL. OZ. (236 mL)
*SEE NOTE ON SIDE PANEL BELOW DRUG FACTS
Products#
Every source-derived product name is available through these pages.
- Canker Sore Relief Rinse
- GOLDENSEAL,MYRRH,ECHINACEA ANGUSTIFOLIA and SODIUM CHLORIDE
- SODIUM CITRATE
- WATER
- ECHINACEA ANGUSTIFOLIA
- MANDARIN OIL
- BITTER ORANGE OIL
- ORANGE OIL
- HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
- SODIUM CHLORIDE
- SODIUM CATION
- CITRIC ACID MONOHYDRATE
- MYRRH
- GOLDENSEAL
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54973-3405 | 54973-3405-1, 54973-3405-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| WATER | 059QF0KO0R | IACT |
| ECHINACEA ANGUSTIFOLIA | VB06AV5US8 | ACTIB |
| MANDARIN OIL | NJO720F72R | IACT |
| BITTER ORANGE OIL | 9TLV70SV6I | IACT |
| ORANGE OIL | AKN3KSD11B | IACT |
| HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) | R33S7TK2EP | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| MYRRH | JC71GJ1F3L | ACTIB |
| GOLDENSEAL | ZW3Z11D0JV | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| b8bc7031-d85b-5ae3-e053-2a95a90aa3ed | 94f7037d-2733-7eda-e053-2a95a90ad6b6 | 2021-01-12 | Warnings | 94f7037d-2733-7eda-e053-2a95a90ad6b6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.