BARBIE- sodium monofluorophosphate paste, dentifrice

Barbie by

Drug Labeling and Warnings

Barbie by is a Otc medication manufactured, distributed, or labeled by Ashtel Studios, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity Toothpaste

Uses

Helps protect teeth and roots against cavities.

Warning

If more than used for brushing is accidently swallowed, seek professional assistance or contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

Directions

Adults and children 2 years of age and older:

• Brush teeth thoroughly after meals or at least twice a day. 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 until good brushing habit are established.
• Children under 2 years of age: Ask a dentist.

Inactive Ingredients

Sorbitol, Water, Silica, Sodium Lauryl Sulfate, Xylitol, Flavor, CMC Sodium Carboxymethyl Cellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red

Other Information

Store at room temperature.

SPL UNCLASSIFIED SECTION

BUBBLE GUM FLAVOR

HELPS PREVENT CAVITIES!

ANTICAVITY FLUORIDE TOOTHPASTE

Alcohol & Sugar Free

QUESTIONS OR COMMENTS?

1-877-274-8358 (U.S.A.)

1-909-434-0911 (INTERNATIONAL)

ONTARIO, CA 91761

DESIGNED IN U.S.A.

MADE IN CHINA

DISTRIBUTED BY ASHTEL STUDIOS INC.

Packaging

INGREDIENTS AND APPEARANCE

BARBIE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-016
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XYLITOL (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ROSE BENGAL SODIUM (UNII: 956575SN5L)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-016-01	119 g in 1 TUBE; Type 0: Not a Combination Product	07/25/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/25/2018

Labeler - Ashtel Studios, Inc. (148689180)