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SPL v1
SPL
SPL Set ID 47896041-0c2e-47b4-90c1-9ef62fc295e1
Route
dental
Published
Effective Date 2023-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
nitrate ion (5 g) fluoride ion (0.24 g)
Inactive Ingredients
sorbitol hydrated silica water polyethylene glycol 1600 sodium lauryl sulfate glycerin carboxymethylcellulose sodium, unspecified sodium pyrophosphate titanium dioxide sodium benzoate sodium phosphate, tribasic, anhydrous saccharin sodium sodium hydroxide methylparaben propylparaben

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2023-03-24

Purpose

Antihypersensitivity Anticavity

Description

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


Medication Information

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

Uses

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

Purpose

Antihypersensitivity

Anticavity

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

Description

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

Section 42229-5

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.

Section 50565-1

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.

Packaging

Drug Facts

Active Ingredients

Potassium Nitrate (5%)

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Questions Or Comments?

1-877-274-8358


Structured Label Content

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

Uses

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

Purpose

Antihypersensitivity

Anticavity

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 (Other information)

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

Inactive Ingredients (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

Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

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.

Packaging

Drug Facts

Active Ingredients (Active ingredients)

Potassium Nitrate (5%)

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Questions Or Comments? (Questions or comments?)

1-877-274-8358


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)