Pro-den Rx

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Pro-den Rx Recall

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Side Effects & Adverse Reactions

Precautions: Limited to topical use in mouth only. DO NOT SWALLOW.

Overdosage: Swallowing a normal treatment dose (approximately 2 mg of fluoride) is not harmful.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

It is well recognized that regular use of 1.1% Neutral Sodium Fluoride (5000 ppm F) in mouthpiece applicators is safe and effective in preventing caries.1-4 Pro-DenRx Brush-On Gel can be applied on a toothbrush as well as a mouthpiece tray. Plaque contributes to caries; therefore, reduction of plaque can help in preventing caries.

Contraindications: Do not use in children under 6 unless recommended by a dentist.

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History

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Other Information

A home care, self-applied topical fluoride treatment containing 1.1% Neutral Sodium Fluoride (5000 ppm F) for daily use in the protection against dental caries.

Sources

Pro-den Rx Manufacturers

Zila Therapeutics, Inc.

Pro-den Rx | Zila Therapeutics, Inc.

Apply daily after usual brushing and flossing at bedtime or more often if your dentist recommends additional therapy based on your diagnosis. Cover brush head with Pro-DenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least one minute. Spit out gel. Adults: Wait 30 minutes before rinsing mouth; Children under 12: Immediately after use, rinse mouth thoroughly with water.

When using a mouthpiece or applicator, cover the inner surface with gel. Place applicator in mouth and bite down lightly for at least 1 minute. Remove applicator and rinse mouth. Clean applicators with cold water.

Store at Room Temperature

How Supplied: Net Wt. 2 oz. (56 g) tube in a box.

Cool Mint: NDC 59883-824-02

References:

1. Accepted Dental Therapeutics Ed. 40 ADA Chicago, p. 405-407, 1984.

2. Englander HR, et al.: JADA 83:354-358 1971.

3. Englander HR, et al.: JADA 78:783-787 1969.

4. Englander HR, et al.: JADA 75:638-644 1967.

Rx only

1-800-228-5595

REORDER NUMBER: 2240MTM

442245 Rev. 1 1008

Made for and Distributed in US by:

Zila Therapeutics, Inc.
P.O. Box 3889, Batesville, AR 72503

No Recall
Zila Therapeutics, Inc.

Pro-den Rx | Zila Therapeutics, Inc.

Apply daily after usual brushing and flossing at bedtime or more often if your dentist recommends additional therapy based on your diagnosis. Cover brush head with Pro-DenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least one minute. Spit out gel. Adults: Wait 30 minutes before rinsing mouth; Children under 12: Immediately after use, rinse mouth thoroughly with water.

When using a mouthpiece or applicator, cover the inner surface with gel. Place applicator in mouth and bite down lightly for at least 1 minute. Remove applicator and rinse mouth. Clean applicators with cold water.

Store at Room Temperature

How Supplied: Net Wt. 2 oz. (56 g) tube in a box.

Berry Fresh: NDC 59883-826-02

References:

1. Accepted Dental Therapeutics Ed. 40 ADA Chicago, p. 405-407, 1984.

2. Englander HR, et al.: JADA 83:354-358 1971.

3. Englander HR, et al.: JADA 78:783-787 1969.

4. Englander HR, et al.: JADA 75:638-644 1967.

Rx only

1-800-228-5595

REORDER NUMBER: 2240RBM

442247 Rev. 1 1008

Made for and Distributed in US by:

Zila Therapeutics, Inc.
P.O. Box 3889, Batesville, AR 72503

No Recall
Zila Therapeutics, Inc.

Pro-den Rx |

No Recall
Zila Therapeutics, Inc.

Pro-den Rx |

No Recall
Zila Therapeutics, Inc.

Pro-den Rx |

No Recall
Zila Therapeutics, Inc.

Pro-den Rx | Zila Therapeutics, Inc.

Directions: Dilute As Directed
Adults and Children 6 years and Older Rinse each day after brushing and flossing, or more often if recommended by dentist based on diagnosis. Into mixing vial put 1/8 oz. (2 pump strokes) of concentrated ProDenRx Rinse. Add water to 1 oz line, tightly snap-on cap and shake well. Vigorously swish between teeth 1/2 of mixture for one minute and then spit out. Repeat procedure with remaining mixture. Do not swallow. Do not rinse mouth, eat or drink for 30 minutes. Rinse mixing vial with water after use. Children 6 to 12 Instruct and supervise in good rinsing habits (to minimize swallowing). Children Under 6 Consult a dentist or doctor.
For Home Irrigation:
Prepare 1 oz of ProDenRex Rinse as described above. Pour into irrigator reservoir, add 4 oz of water and mix thoroughly. Use irrigator as directed. Rinse irrigator with water after use.
Other information: 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.

No Recall
Zila Therapeutics, Inc.

Pro-den Rx | Zila Therapeutics, Inc.

Adults and Children over 6 years of age: Use in place of your regular toothpaste. Apply at bedtime or more often if your dentist recommends additional therapy based on the diagnosis. Cover brush head with ProDenRx 1.1% Neutral Sodium Fluoride Gel and brush around all tooth surfaces and gum line for at least 1 minute. Spit out gel.

Adults: Wait 30 minutes before rinsing mouth. For children under age 12: Rinse mouth thoroughly immediately after use.

Store at Room Temperature

How Supplied: Net Wt. 2 oz. (56 g) tube in a box.

Berry Fresh: NDC 59883-822-02

Cherry Limeade: NDC 59883-821-02

Cool Mint: NDC 59883-820-02

References:

1. Accepted Dental Therapeutics Ed. 40 ADA Chicago, p. 405-407, 1984.
2. Englander HR, et al.: JADA 83:354-358 1971.
3. Englander HR, et al.: JADA 78:783-787 1969.
4. Englander HR, et al.: JADA 75:638-644 1967.

Rx Only

1-800-228-5595

REORDER NUMBER: 2250RBM

Made for and Distributed in US by: Zila Therapeutics, Inc.
P.O. Box 3889, Batesville, AR 72503

No Recall
Zila Therapeutics, Inc.

Pro-den Rx | Zila Therapeutics, Inc.

Adults and children over age 6 years: Rinse once a week, preferably at bedtime, after thoroughly brushing and flossing teeth. Rinse more often if your dentist recommends additional therapy based on your diagnosis. Pour 10 ml (2 teaspoons) of ProDenRx 0.2% Sodium Fluoride Rinse into the graduated cup using the markings on its side. Swish vigorously around and between the teeth for one minute, then spit out. DO NOT SWALLOW. For maximum benefit, do not eat, drink, or rinse mouth for at least 30 minutes after use. Children 6 to 12 years old: Supervise while using this product. Children Under 6 years old: Consult your dentist or doctor before using.

No Recall
Zila Therapeutics, Inc.

Pro-den Rx | Zila Therapeutics, Inc.

Directions:
Adults and Children 6 Years and Older This is a fluoride preventive treatment gel, not a toothpaste. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Children 6 to 12 Instruct and supervise brushing and rinsing (to minimize swallowing) until good brushing habits are established. Children Under 6 Ask a dentist or doctor.
Other Information: This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dental professional.

No Recall