BRUSH BUDDIES VALUE 2 PACK WHITENING- sodium monofluorophosphate paste, dentifrice

Brush Buddies Value 2 pack Whitening by

Drug Labeling and Warnings

Brush Buddies Value 2 pack Whitening 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 ingredient

Sodium Monofluorophosphate (0.76%)

(Total fluoride content - 1000 ppm approx.)

Purpose

Anticavity

INDICATIONS & USAGE

Use Regular brushing with fluoride toothpaste helps protect teeth against cavities.

WARNINGS

Warnings Keep out of reach of children under 6years of age. If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions  adults and children 2 years & 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 Supervise children's brushing until good habits are established Children under 2 years of age: Consult a dentist or doctor. Do not swallow.

INACTIVE INGREDIENT

Inactive ingredients calcium carbonate, aqua, sorbitol, precipitated silica, sodium lauryl sulphate, flavor, sodium silicate, tetra sodium pyrophosphate, xanthan gum, sodium carboxy methyl cellulose, benzyl alcohol, sodium benzoate, baking soda, sodium saccharin, titanium dioxide, polyethylene glycol 400, FD&C blue #1

SPL UNCLASSIFIED SECTION

TWO 3.5 OZ (99 g) TUBES TOTAL NET WT 7 OZ (198 g)

VALUE 2 PACK

FIGHTS TARTAR AND HELPS WHITEN TEETH*

WITH BAKING SODA

COOL MINT

CAVITIES   TARTAR

PLAQUE     BREATH

ENAMEL     WHITENS

*HELPS WHITEN TEETH WITH REGULAR BRUSHING TWICE A DAY

DESIGNED IN U.S.A.  MADE IN INDIA

Brush Buddies®

WWW.BRUSHBUDDIES.COM

QUESTIONS OR COMMENTS?

1-877-274-8358 TOLL FREE IN USA
1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CALIFORNIA 91761

Packaging

INGREDIENTS AND APPEARANCE

BRUSH BUDDIES VALUE 2 PACK WHITENING 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-030
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
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue (Light blue)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-030-01	2 in 1 BOX	12/15/2019
1		99 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/15/2019

Labeler - Ashtel Studios, Inc (148689180)