KUNDAL SENSITIVE DENTAL CARE TOOTH (APPLE CHAMOMILE MINT)- tribasic calcium phosphate paste 
THESKINFACTORY Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Tricalcium Phosphate

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

for dental care

KEEP OUT OF REACH OF THE CHILDREN

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.

Do not swallow.

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

For dental use only

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KUNDAL SENSITIVE DENTAL CARE TOOTH (APPLE CHAMOMILE MINT) 
tribasic calcium phosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74773-0040
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION17 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A)  
SORBITOL (UNII: 506T60A25R)  
XYLITOL (UNII: VCQ006KQ1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74773-0040-12 in 1 BOX09/01/2020
1150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/2020
Labeler - THESKINFACTORY Co., Ltd. (694804099)
Registrant - THESKINFACTORY Co., Ltd. (694804099)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO., LTD.557810721manufacture(74773-0040)
Establishment
NameAddressID/FEIBusiness Operations
THESKINFACTORY Co., Ltd.694804099label(74773-0040)

Revised: 9/2020
Document Id: af54cf82-6779-7ac6-e053-2a95a90a0ae2
Set id: af3cb338-1bff-5b78-e053-2995a90a1310
Version: 2
Effective Time: 20200915
 
THESKINFACTORY Co., Ltd.