SPL v3
SPL
SPL Set ID 47142a7d-3095-4ea6-b977-80e9f2cc8958
Route
DENTAL
Published
Effective Date 2017-12-22
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.3408 g)
Inactive Ingredients
Glycerin Methylparaben Propylparaben Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2013-02-01

Description

Stannous Fluoride 0.63% Concentrate (0.12% w/v fluoride ion).

Indications and Usage

Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product mist be used under the supervision of a dentist.

Purpose

Anticavity, antigingivitis, antihypersensitivity mouthrinse


Medication Information

Indications and Usage

Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product mist be used under the supervision of a dentist.

Purpose

Anticavity, antigingivitis, antihypersensitivity mouthrinse

Description

Stannous Fluoride 0.63% Concentrate (0.12% w/v fluoride ion).

Section 51945-4

Purpose:

Anticavity, antigingivitis, antihypersensitivity mouthrinse

Warnings:
  • Keep out of reach of children.

    Do not swallow. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • Do not use until diluted.

    This product may produce surface staining of the teeth.

    Adequate tooth-brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
Directions:

Adults and children 6 years of age and older:

  • Do not use before mixing with water. Use immediately after preparing the rinse.
  • Remove cap and replace with pump.
  • Rotate spout container clockwise to extend.
  • Depress pump until rinse comes to the tip of the pump.
  • Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well.
  • Vigorously swish rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
  • Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 6 years of age:

  • Consult a dentist or doctor.
Active Ingredient:

Stannous Fluoride 0.63% Concentrate (0.12% w/v fluoride ion).

Other Information:

Store at controlled room temperature 59° - 86°F (15°-30°C). Protect from freezing.

Inactive Ingredients:

Flavor, Glycerin, Methyl paraben, Propyl paraben and Sodium Saccharin.

Indications and Usage:

Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product mist be used under the supervision of a dentist.


Structured Label Content

Section 51945-4 (51945-4)

Purpose:

Anticavity, antigingivitis, antihypersensitivity mouthrinse

Warnings:
  • Keep out of reach of children.

    Do not swallow. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • Do not use until diluted.

    This product may produce surface staining of the teeth.

    Adequate tooth-brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
Directions:

Adults and children 6 years of age and older:

  • Do not use before mixing with water. Use immediately after preparing the rinse.
  • Remove cap and replace with pump.
  • Rotate spout container clockwise to extend.
  • Depress pump until rinse comes to the tip of the pump.
  • Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well.
  • Vigorously swish rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
  • Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 6 years of age:

  • Consult a dentist or doctor.
Active Ingredient:

Stannous Fluoride 0.63% Concentrate (0.12% w/v fluoride ion).

Other Information:

Store at controlled room temperature 59° - 86°F (15°-30°C). Protect from freezing.

Inactive Ingredients:

Flavor, Glycerin, Methyl paraben, Propyl paraben and Sodium Saccharin.

Indications and Usage:

Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product mist be used under the supervision of a dentist.


Advanced Ingredient Data


Raw Label Data

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