BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON- sodium fluoride liquid

BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON by

Drug Labeling and Warnings

BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON by is a Otc medication manufactured, distributed, or labeled by Kingkey MBC Life Technology Group co., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

SODIUM FLUORIDE 0.03%

Purpose

（0.02% w/v fluoride ion)----Anticavity

uses

helps protect teeth against cavities.

Warnings

Keep out of reach of children under 6 years of age.lf you accidentally swallow more than used for rinsing, seek professional help or contact a Poison Control Center immediately.

WARNINGS

Keep out of reac of children under 6 years of age, lf youaccidentally swallow more than used for rinsing, seek professionahelp or contact a Poison Control Center immediately.

Directions

Adults and children 6 years and older:

• Use daily after you brush your teeth with toothpaste.
• Rinse toothpaste from mouth prior to use.
• Shake well before each use.
• Twist and remove cap.
• Rinse or gargle for 30 seconds with 15 ml and spit out
• Do Not swallow the rinse.
• Do Not eat or drink for 30 minutes after rinsing.
• Supervise children as necessary.
• Children under 6 years of age, consult with a dentist or doctor.

Inactive ingredients

Water
SORBITOL
GLYCERIN
XYLITOL

SODIUM BENZOATE
POTASSIUM SORBATE
PEG-40 HYDROGENATED CASTOR OIL
FLAVOR
SODIUM SACCHARIN
CETYLPYRIDINIUM CHLORIDE

METHYL DIISOPROPYL PROPIONAMIDE
SUCRALOSE
CITRIC ACID
FD&C Yellow No.5（CI 19140）
FD&C Blue No.1（CI 42090）

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73928-016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.03 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73928-016-01	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	05/01/2024

Labeler - Kingkey MBC Life Technology Group co., LTD. (545349263)

Establishment
Name	Address	ID/FEI	Business Operations
Kingkey MBC Life Technology Group co., LTD.		545349263	manufacture(73928-016)