ULTIMATE WHITE SENSITIVE WHITENING- potassium nitrate, sodium fluoride paste, dentifrice

Ultimate White Sensitive Whitening by

Drug Labeling and Warnings

Ultimate White Sensitive 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 amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

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 for at least one minute, preferably after each meal or at least twice a day (morning and evening) as recommended by a dentist or physician. 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.

Other information

Store at room temperature 68-77°F (20-25°C)

Inactive ingredients

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

Questions or comments?

1-877-274-8358

SPL UNCLASSIFIED SECTION

TWIN PACK

SENSITIVE TOOTHPASTE

MAXIMUM STRENGTH WITH FLUORIDE

FOR SENSITIVE TEETH AND CAVITY PROTECTION
RELIEVES PAINFUL SENSITIVITY

EXTRA WHITENING

DESIGNED IN U.S.A.
MANUFACTURED IN INDIA

Brush Buddies®
BRUSHBUDDIES.COM    ONTARIO, CA 91761

QUESTIONS OR COMMENTS?
1-877-274-8358 TOLL FREE IN U.S.A.
1-909-434-0911 INTERNATIONAL

COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE
DISTRIBUTED BY ASHTEL STUDIOS INC.

Packaging

INGREDIENTS AND APPEARANCE

ULTIMATE WHITE SENSITIVE WHITENING 
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70108-075
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70108-075-01	2 in 1 BOX	03/24/2023
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 not final	part356	03/24/2023

Labeler - Ashtel Studios, Inc. (148689180)