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

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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Brush Buddies® Whitening Anti-Cavity Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium Monofluorophosphate (0.76%)

(Total fluoride content - 1000 ppm approx.)

Purpose

Anticavity

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

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.

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 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

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

image description

BRUSH BUDDIES VALUE 2 PACK WHITENING 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-030
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
Colorblue (Light blue) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70108-030-012 in 1 BOX12/15/2019
199 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/15/2019
Labeler - Ashtel Studios, Inc (148689180)

Revised: 3/2023
Document Id: 6e54b59d-672f-447b-8d16-90ce7c5cb6f9
Set id: 636bf51d-9750-4305-ab4a-3483c9f0169b
Version: 2
Effective Time: 20230325
 
Ashtel Studios, Inc