Label: KIDS ORAL CARE STRAWBERRY FLAVOR- xylitol, calcium lactate spray

  • NDC Code(s): 82711-101-01, 82711-101-02
  • Packager: TOOTHFILM INC.
  • 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.

Drug Label Information

Updated March 7, 2025

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients: Xylitol 2.0mL/20mL; Calcium Lactate 0.02mL/20mL

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Glycerin, Sodium Levulinate, Sodium Anisate, Trehalose, Sodium Chloride, Dicalcium Phosphate, Silica, Calcium Oxide

  • PURPOSE

    Purpose: Anticavity

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children: For external use only. Keep out of reach of children. Avoidcontact with eyes. Discontinue use if signs of irritation or rash occur.

  • INDICATIONS & USAGE

    Helps protect against cavities. Spray 2 to 3 times towards children's teeth to prevent plaque build up and cavities.

  • WARNINGS

    Warnings: Avoid spraying in eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor or pharmacist if you have an allergic reaction to this product or any of its ingredients.

  • DOSAGE & ADMINISTRATION

    Directions: 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.

  • QUESTIONS

    Question: support@lab52.com

  • OTHER SAFETY INFORMATION

    Other: Store at 20°C to 25°C (68°F to 77°F) Use product within 90 days of opening.

  • PRINCIPAL DISPLAY PANEL

    Kids Oral Spray Strawberry FlavorSee Label

  • INGREDIENTS AND APPEARANCE
    KIDS ORAL CARE STRAWBERRY FLAVOR 
    xylitol, calcium lactate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82711-101
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM LACTATE (UNII: 2URQ2N32W3) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM LACTATE0.02 mg  in 20 mg
    XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL2 mg  in 20 mg
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82711-101-021 in 1 BOX03/13/2025
    1NDC:82711-101-0120 mg in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/13/2025
    Labeler - TOOTHFILM INC. (656036549)
    Establishment
    NameAddressID/FEIBusiness Operations
    JUN DA BEAUTY-TEC CO., LTD.658442561manufacture(82711-101) , label(82711-101)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!