BRUSH BUDDIES TOTAL CARE ANTI-CAVITY PROTECTION- sodium monofluorophosphate paste, dentifrice

Brush Buddies TOTAL CARE ANTI-CAVITY Protection by

Drug Labeling and Warnings

Brush Buddies TOTAL CARE ANTI-CAVITY Protection 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%
(0.13% w/v Fluoride ion)

Purpose

Anticavity

Uses

helps protect against cavities.

Warnings

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

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.
children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

Sorbitol, Hydrated Silica, Treated Water (Aqua), Poly Ethylene Glycol 1500 (PEG 32), Sodium Lauryl Sulphate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide (Cl 77891), Tetra Sodium Pyrophosphate, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Trisodium Phosphate

Questions or comments?

call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

FRESH PEPPERMINT

ANTI-CAVITY FLUORIDE TOOTHPASTE

FRESHENS BREATH
STRENGTHENS TEETH WITH ACTIVE FLUORIDE

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 TOTAL CARE ANTI-CAVITY PROTECTION 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-078
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT (Fresh peppermint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-078-01	1 in 1 BOX	09/07/2023
1		113 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	M021	09/07/2023

Labeler - Ashtel Studios, Inc. (148689180)