KUNDAL SENSITIVE DENTAL CARE TOOTH (APPLE CHAMOMILE MINT)- tribasic calcium phosphate paste

KUNDAL Sensitive Dental Care Tooth (Apple Chamomile Mint) by

Drug Labeling and Warnings

KUNDAL Sensitive Dental Care Tooth (Apple Chamomile Mint) by is a Otc medication manufactured, distributed, or labeled by THESKINFACTORY Co., Ltd., DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tricalcium Phosphate

INACTIVE INGREDIENT

Sorbitol
Water
Sodium Cocoyl Glutamate
Cellulose Gum
PEG-32
Apple chamomile mint flavor
Menthol
Sodium Benzoate
Xylitol
Stevioside
Camellia Sinensis Leaf Extract
Aloe Barbadensis Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Salvia Officinalis (Sage) Leaf Extract
Eucalyptus Globulus Leaf Extract

PURPOSE

for dental care

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

WARNINGS

Do not swallow.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KUNDAL SENSITIVE DENTAL CARE TOOTH (APPLE CHAMOMILE MINT) 
tribasic calcium phosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74773-0040
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	17 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74773-0040-1	2 in 1 BOX	09/01/2020
1		150 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/01/2020

Labeler - THESKINFACTORY Co., Ltd. (694804099)

Registrant - THESKINFACTORY Co., Ltd. (694804099)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(74773-0040)

Establishment
Name	Address	ID/FEI	Business Operations
THESKINFACTORY Co., Ltd.		694804099	label(74773-0040)