BRUSHBUDDIES SHOPKINS ANTICAVITY TOOTH- sodium monofluorophosphate paste, dentifrice

Brushbuddies Shopkins Anticavity Tooth by

Drug Labeling and Warnings

Brushbuddies Shopkins Anticavity Tooth 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 Monofluorophosphate 0.5%

PURPOSE

Purpose:

Anticavity

INDICATIONS & USAGE

Uses:

Help protect teeth and roots 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 under 6 years of age

DOSAGE & ADMINISTRATION

Directions:

• Adults and children 2 years and older:
• Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
• Do not swallow
• To minimize swallowing use a pea-sized amount in children under 6 years of age,
• Supervise children's brushing untill good habits are established.

Children under 2 years of age:

• Ask a dentist

INACTIVE INGREDIENT

Inactive Ingredients:

Sorbitor, Water, Silica, Sodium N-Lauroylsarcosinate, Xylitol, Flavor, Sodium Carboxymethylcellulose, Sodium Benzoate, Xanthan Gum, Sodium Pyrophosphate, Saccharin Sodium, Rose Red 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRUSHBUDDIES SHOPKINS ANTICAVITY TOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-501
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.066 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-501-01	119 g in 1 TUBE; Type 0: Not a Combination Product	11/29/2016

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(70108-501)