CANKER SORE RELIEF RINSE- goldenseal,myrrh,echinacea angustifolia and sodium chloride liquid
Hyland's

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Hyland's Canker Sore Relief Rinse

Drug Facts

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.

Do not use more than directed. DO NOT SWALLOW.

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.

Keep this and all medications out of the reach of children.

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

* 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

carton

CANKER SORE RELIEF RINSE
goldenseal,myrrh,echinacea angustifolia and sodium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3405
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	6 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	30 [hp_X] in 1 mL
MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L)	MYRRH	4 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MANDARIN OIL (UNII: NJO720F72R)
BITTER ORANGE OIL (UNII: 9TLV70SV6I)
ORANGE OIL (UNII: AKN3KSD11B)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-3405-1	1 in 1 CARTON	11/01/2019	01/12/2021
1		236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:54973-3405-2	5 mL in 1 PACKET; Type 0: Not a Combination Product	11/01/2019	01/12/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/01/2019	01/12/2021

Labeler - Hyland's (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Applied Laboratories, Inc.		876754375	manufacture(54973-3405) , pack(54973-3405) , label(54973-3405)

Revised: 1/2021

Document Id: b8bc7031-d85b-5ae3-e053-2a95a90aa3ed

Set id: 94f7037d-2733-7eda-e053-2a95a90ad6b6

Version: 2

Effective Time: 20210112

Hyland's