BRUSHBUDDIES SHOPKINS ANTICAVITY FLUORIDE- sodium fluoride mouthwash

Brushbuddies Shopkins Anticavity Fluoride by

Drug Labeling and Warnings

Brushbuddies Shopkins Anticavity Fluoride by is a Otc medication manufactured, distributed, or labeled by Ashtel Studio Inc, Foshan Nanhai JiaChun Biology Engineering Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Sodium Fluoride 0.05%

PURPOSE

Purpose:

Anticavity

INDICATIONS & USAGE

Uses:

Helps protect against cavities

WARNINGS

Warnings:

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

Directions:

• Adults and children 6 years and older:
• Use daily after your normal brush
• Shake well before each use
• Rinse or gargle for 30 seconds with 15 mL (3 teaspoonful) and then spit out
• Supervise children's brushing untill good habits are established.
• Do not Swallow the rinse

STORAGE AND HANDLING

Other Information

Store in cool and dry place away from direct sun light

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Xylitor, Flavor, Acesulfame, Sodium Benzoate, Saccharin Sodium, Rose Red 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRUSHBUDDIES SHOPKINS ANTICAVITY FLUORIDE 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-502
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0225 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
ACESULFAME (UNII: MA3UYZ6K1H)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ROSE BENGAL AT (UNII: 1IID5XA5GB)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-502-01	500 g in 1 BOTTLE; Type 0: Not a Combination Product	12/03/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/28/2016

Labeler - Ashtel Studio Inc (148689180)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Nanhai JiaChun Biology Engineering Co., Ltd		527935253	manufacture(70108-502)