Label: KIDS ORAL CARE VANILLA FLAVOR- xylitol, calcium lactate spray
- NDC Code(s): 82711-103-01, 82711-103-02
- Packager: TOOTHFILM INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated March 13, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Spray after meals and feedings. Don’t forget to brush kid's teeth for the best results! It’s fluoride-free, preservative-free, and safe to swallow when used as directed!
Apply the spray on the kiddo's teeth surface to form a protective coating. • Do not spit the spray out. • Do not rinse with water after spray. This spray is not intend to replace brushing or flossing.
- WARNINGS
- DOSAGE & ADMINISTRATION
- QUESTIONS
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIDS ORAL CARE VANILLA FLAVOR
xylitol, calcium lactate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82711-103 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM LACTATE (UNII: 2URQ2N32W3) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM LACTATE 0.02 mg in 20 mg XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL 2 mg in 20 mg Inactive Ingredients Ingredient Name Strength SODIUM ANISATE (UNII: F9WFJ28MV9) SODIUM LEVULINATE (UNII: VK44E1MQU8) SODIUM CHLORIDE (UNII: 451W47IQ8X) CALCIUM OXIDE (UNII: C7X2M0VVNH) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SILICA (UNII: ETJ7Z6XBU4) DICALCIUM PHOSPHATE (UNII: L11K75P92J) TREHALOSE (UNII: B8WCK70T7I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82711-103-02 1 in 1 BOX 03/13/2025 1 NDC:82711-103-01 20 mg in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/13/2025 Labeler - TOOTHFILM INC. (656036549) Establishment Name Address ID/FEI Business Operations JUN DA BEAUTY-TEC CO., LTD. 658442561 manufacture(82711-103) , label(82711-103)