BRUSHBUDDIES BARBIE ANTICAVITY FLUORIDETOOTH- sodium monofluorophosphate paste, dentifrice

Brushbuddies Barbie Anticavity FluorideTooth by

Drug Labeling and Warnings

Brushbuddies Barbie Anticavity FluorideTooth by is a Otc medication manufactured, distributed, or labeled by Foshan Nanhai Jiachun Biology Engineering Co., Ltd., Foshan Nanhai JiaChun Biology Engineering Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Sodium Monofluorophosphate 0.76%

PURPOSE

Purpose:

Anticavity Toothpaste

INDICATIONS & USAGE

Uses:

Help protect teeth and roots against cavities

WARNINGS

Warnings:

If morethan used for brushing is 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 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 Lauryl Sulfate,  Xylitol, Flavor, Sodium Carboxymethylcellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRUSHBUDDIES BARBIE ANTICAVITY FLUORIDETOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71106-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71106-003-01	119 g in 1 TUBE; Type 0: Not a Combination Product	08/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/02/2018

Labeler - Foshan Nanhai Jiachun Biology Engineering Co., Ltd. (527935253)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Nanhai JiaChun Biology Engineering Co., Ltd		527935253	manufacture(71106-003)