60 Second Taste Strawberry

60 Second Taste Strawberry
SPL v5
SPL
SPL Set ID 1235c694-a139-4d07-e054-00144ff8d46c
Routes
BUCCAL DENTAL TOPICAL
Published
Effective Date 1988-04-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (27.73 mg)

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
UNAPPROVED DRUG OTHER Active Since 1988-04-01

Description

Active Ingredient: 1.23% w/w fluoride ion from 2.72% sodium fluoride

Contraindications

Contraindicated in individuals who are hypersensitive to fluoride.


Medication Information

Contraindications

Contraindicated in individuals who are hypersensitive to fluoride.

Description

Active Ingredient: 1.23% w/w fluoride ion from 2.72% sodium fluoride

Section 51945-4

60 Second Taste Gel

Anticavity Topical APF*

Preventive Treatment Gel

*Acidulated Phosphate Fluoride

Strawberry

Contains:

Active Ingredient: 1.23% w/w fluoride ion from 2.72% sodium fluoride

Contraindications:

Contraindicated in individuals who are hypersensitive to fluoride.

Warnings & Precautions

Keep out of reach of children. For topical intraoral use only. For Professionally applied in office fluoride treatment only.

Not for system treatment. Do not swallow.

Do not use on patients with an allergy to fluoride.

60 Second Taste contains artificial color and flavor; confirm that no known patient allergies exist. Marshmallow and Chocolate Vanilla are dye free and contain no artificial colors.

Special care should be used when administering to children under 6 years of age so that gel is not swallowed.

Contact with abraided or sensitive oral tissue may produce discomfort.

If more than is ordinarily used for treatment is swallowed, administer calcium such as milk and contact your local Poison Control Center immediately.

Other Safety Information

For product MSDS information please see company website at pascaldental.com or contact Pascal directly.

Pascal's 60 Second Taste is free of gluten, soy, milk, egg, peanut and tree nut products.

Rx only in USA. For Professional Use Only.

Dosage and Directions for Use

Usual dosage is approximately 2.75 - 9 grams of 60 Second Taste per dual arch treatment (depending on tray size).

Shake well before use

  • After prophylaxis remove excess fluid from teeth.
  • Fill applicator tray 1/3 full with gel.
  • Insert filled tray into patient's mouth and instruct to bite down gently for one minute, or up to four minutes.
  • After treatment time is completed, remove tray and have patient expectorate residual gel.
  • For maximum benefits for the prevention of caries, instruct patient not to rinse, eat or drink for 30 minutes.

Repeat treatment at least once or twice a year. For patients with rampant or active caries, repeat treatment once or twice every six months.

If contents have become frozen, warm to room temperature and shake well before using.


Structured Label Content

Section 51945-4 (51945-4)

60 Second Taste Gel

Anticavity Topical APF*

Preventive Treatment Gel

*Acidulated Phosphate Fluoride

Strawberry

Contains:

Active Ingredient: 1.23% w/w fluoride ion from 2.72% sodium fluoride

Contraindications:

Contraindicated in individuals who are hypersensitive to fluoride.

Warnings & Precautions

Keep out of reach of children. For topical intraoral use only. For Professionally applied in office fluoride treatment only.

Not for system treatment. Do not swallow.

Do not use on patients with an allergy to fluoride.

60 Second Taste contains artificial color and flavor; confirm that no known patient allergies exist. Marshmallow and Chocolate Vanilla are dye free and contain no artificial colors.

Special care should be used when administering to children under 6 years of age so that gel is not swallowed.

Contact with abraided or sensitive oral tissue may produce discomfort.

If more than is ordinarily used for treatment is swallowed, administer calcium such as milk and contact your local Poison Control Center immediately.

Other Safety Information

For product MSDS information please see company website at pascaldental.com or contact Pascal directly.

Pascal's 60 Second Taste is free of gluten, soy, milk, egg, peanut and tree nut products.

Rx only in USA. For Professional Use Only.

Dosage and Directions for Use (Dosage and directions for Use)

Usual dosage is approximately 2.75 - 9 grams of 60 Second Taste per dual arch treatment (depending on tray size).

Shake well before use

  • After prophylaxis remove excess fluid from teeth.
  • Fill applicator tray 1/3 full with gel.
  • Insert filled tray into patient's mouth and instruct to bite down gently for one minute, or up to four minutes.
  • After treatment time is completed, remove tray and have patient expectorate residual gel.
  • For maximum benefits for the prevention of caries, instruct patient not to rinse, eat or drink for 30 minutes.

Repeat treatment at least once or twice a year. For patients with rampant or active caries, repeat treatment once or twice every six months.

If contents have become frozen, warm to room temperature and shake well before using.


Advanced Ingredient Data


Raw Label Data

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