BRUSH BUDDIES SENSITIVE EXTRA WHITENING- potassium nitrate, sodium fluoride paste, dentifrice

Brush Buddies SENSITIVE Extra Whitening by

Drug Labeling and Warnings

Brush Buddies SENSITIVE Extra 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 ingredients

Potassium Nitrate 5%
Sodium Fluoride 0.24% (0.15 % w/v Fluoride ion)

Purpose

Antihypersensitivity
Anticavity

Uses

builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact aids in the prevention of dental cavities.

Warnings

Stop use and ask a dentist if  the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.  pain/sensitivity still persists after 4 weeks of use.

Keep out of reach of children under 12 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 12 years & older:  apply at least a 1-inch strip of the product onto a soft bristle toothbrush 
brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Make sure to brush all sensitive areas of the teeth.
minimize swallowing. Spit out after brushing.
children under 12 years of age: Consult a dentist or doctor.

Inactive ingredients

Sorbitol, Hydrated Silica, Treated Water, PEG-1500, Sodium Lauryl Sulphate, Flavor, Glycerin, Cellulose Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, Sodium Benzoate, Trisodium Phosphate, Sodium Saccharin, Sodium Hydroxide, Methylparaben, Propylparaben

Questions or comments?

call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

FRESH MINT

FRESHENS BREATH
STRENGTHENS TEETH WITH ACTIVE FLUORIDE

Compares to the active ingredients in Sensodyne® Extra Whitening*

*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Sensodyne®.

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 SENSITIVE EXTRA WHITENING 
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-079
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.24 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)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Fresh mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-079-01	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	M022	09/07/2023

Labeler - Ashtel Studios, Inc. (148689180)