Label: KUNDAL SENSITIVE DENTAL CARE TOOTH (APPLE CHAMOMILE MINT)- tribasic calcium phosphate paste
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated September 15, 2020
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- ACTIVE INGREDIENT
Sodium Cocoyl Glutamate
Apple chamomile mint flavor
Camellia Sinensis Leaf Extract
Aloe Barbadensis Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Salvia Officinalis (Sage) Leaf Extract
Eucalyptus Globulus Leaf Extract
- KEEP OUT OF REACH OF 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.
- DOSAGE & ADMINISTRATION
- 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)