BRUSHBUDDIES BARBIE ANTICAVITY FLUORIDETOOTH- sodium monofluorophosphate paste, dentifrice
Foshan Nanhai Jiachun Biology Engineering Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Sodium Monofluorophosphate 0.76%

Purpose:

Anticavity Toothpaste

Uses:

Help protect teeth and roots against cavities

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

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 Ingredients:

Sorbitor, Water, Silica, Sodium Lauryl Sulfate, Xylitol, Flavor, Sodium Carboxymethylcellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red 1

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

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