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

CANKER SORE HEALING DOTS by

Drug Labeling and Warnings

CANKER SORE HEALING DOTS by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

WARNINGS

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.

INACTIVE INGREDIENT

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

PURPOSE

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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]

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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

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

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3343) , pack(54973-3343) , label(54973-3343)

Establishment
Name	Address	ID/FEI	Business Operations
Merical, Inc		118445308	pack(54973-3343)