KIDS ORAL CARE STRAWBERRY FLAVOR- xylitol, calcium lactate spray

Kids Oral Care Strawberry Flavor by

Drug Labeling and Warnings

Kids Oral Care Strawberry Flavor by is a Otc medication manufactured, distributed, or labeled by TOOTHFILM INC., JUN DA BEAUTY-TEC CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

See Label

INGREDIENTS AND APPEARANCE

KIDS ORAL CARE STRAWBERRY FLAVOR 
xylitol, calcium lactate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82711-101
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: 82711-101-02	1 in 1 BOX	03/13/2025
1	NDC: 82711-101-01	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(82711-101) , label(82711-101)