CANKER SORE HEALING DOTS- sodium borate, calendula officinalis flowering top, causticum, daphne mezereum bark and sodium chloride tablet
Hyland's Inc.

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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Canker Sore Healing Dots

Drug Facts

Active ingredients	Purpose
Borax 6X HPUS	canker sores, sores or ulcers in mouth
Calendula 6X HPUS	canker and mouth sores
Causticum 6X HPUS	discomfort of gums and cheek due to canker sores, sores in mouth
Mezereum 12X HPUS	canker sores, discomfort of tongue or gums due to canker sores
Natrum Muriaticum 6X HPUS	discomfort of gums and cheek due to canker sores, sores in mouth

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

Temporarily relieves the symptoms of sores and ulcers in mouth,discomfort of gums or tongue due to canker sores.

As with any drug, ask doctor before use if pregnant or breast-feeding.

Do not use•more than directed  •if you have a known allergy to any ingredient in this product.

Consult a physician

Consult a physician if:

 •symptoms persist for more than 72 hours or worsen

 •swelling increases, 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 accidental overdose, contact a medical professional or Poison Control Center immediately.

Tamper Band Safety

Do not use if imprinted tamper band is broken or missing.

In case of emergency

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

Children 2 years to under 6 years of age:Consult a licensed healthcare professional before using this product.

Children 6 years to under 12 years of age:Dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Adults and Children 12 years and over:Dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

Temporarily relieves the symptoms of sores and ulcers in mouth, discomfort of gums or tongue due to canker sores.

PRINCIPAL DISPLAY PANEL - 50 TABLET CARTON

NDC 54973-3343-1

HOMEOPATHIC

Natural

Relief

SINCE 1903

Hyland's®

CANKER SORE*

HEALING DOTS

RELIEF TABLETS

BENZOCAINE FREE

GENTLE PAIN RELIEF

COATES AND SOOTHES

WITHOUT NUMBING

OR BURNING

FOR MOUTH SORES

& ABRASIONS

50 QUICK-DISSOLVING

TABLETS

ACTUAL SIZE

194 MG

CANKER SORE HEALING DOTS
sodium borate, calendula officinalis flowering top, causticum, daphne mezereum bark and sodium chloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3343
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV)	DAPHNE MEZEREUM BARK	12 [hp_X]
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X]
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	6 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	6 [hp_X]
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	6 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-3343-1	1 in 1 CARTON	08/17/2017
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:54973-3343-2	4 in 1 PACKET; Type 0: Not a Combination Product	08/17/2017	12/28/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/17/2017	10/19/2023

Labeler - Hyland's Inc. (008316655)

Name	Address	ID/FEI	Business Operations
Establishment
Hyland's Inc.		008316655	manufacture(54973-3343) , pack(54973-3343) , label(54973-3343)

Revised: 10/2023

Document Id: 0812f0c1-ccc4-6586-e063-6394a90a4999

Set id: 5928225b-c63c-acff-e053-2991aa0ae653

Version: 5

Effective Time: 20231019

Hyland's Inc.