BUBBLE GUM FLAVOR FOR KIDS 25G 50G- bubble gum flavor toothpaste for kids 25g 50g ointment

Bubble Gum Flavor For Kids 25g 50g by

Drug Labeling and Warnings

Bubble Gum Flavor For Kids 25g 50g by is a Otc medication manufactured, distributed, or labeled by WORLD DENTISTS ASSOCIATION AMERICA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Sodium Fluoride 0.25%

Purpose

Anticavity

Use

Use helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age.
If more than used for brushing is accidentally
swallowed, get medical help or contact a Poison
Control Center right away.

Do not use

Do not apply on open skin wounds

WHEN USING

In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Minimize swallowing

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age.

Directions

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 physician
Children 2 to 6 years
Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
Children under 2years
Ask a dentist or physician

Other information

Store in a cool place, below 86° F, away from heat
Do not use if quality seal is broken or missing
Do not use after the expiration date

Inactive ingredients

Inactive ingredients Sorbitol, Aqua, Hydrated Silica,
PEG-300, Glycerin, Sodium Lauryl Sulfate, Flavor, Cellulose
Gum, Xanthan Gum, Sodium Benzoate, Carrageenan, Saccharin
Sodium, Sodium Pyrophosphate, FD&C Blue No.1.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

BUBBLE GUM FLAVOR FOR KIDS 25G 50G 
bubble gum flavor toothpaste for kids 25g 50g ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85215-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SORBITOL (UNII: 506T60A25R)
AQUA (UNII: 059QF0KO0R)
SILICA (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL 14000 (UNII: 77HY82S0LG)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARRAGEENAN (UNII: 5C69YCD2YJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85215-001-01	25 g in 1 TUBE; Type 0: Not a Combination Product	05/17/2025
2	NDC: 85215-001-02	50 g in 1 TUBE; Type 0: Not a Combination Product	05/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	05/17/2025

Labeler - WORLD DENTISTS ASSOCIATION AMERICA LIMITED (663274349)

Establishment
Name	Address	ID/FEI	Business Operations
WORLD DENTISTS ASSOCIATION AMERICA LIMITED		663274349	manufacture(85215-001)