DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.63 mg)

Inactive Ingredients

Edetic Acid Glycerin Saccharin Sodium Xylitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-08-03

Medication Information

Purpose

Anticavity/antigingivitis

Description

Stannous fluoride, 0.63%

Uses

Aids in the prevention of dental decay

Helps prevent gingivitis

Helps interfere with harmful effects of plaque associated with gingivitis

Section 42229-5

Manufactured by Dharma Research, Inc.

www.dharmaresearch.com

5220 N.W. 72 Avenue, Unit 15

Miami, FL 33166

1-877-833-3725

Reorder#: 56-00135

Section 50565-1

Keep out of reach of children under 6 years of age. If more than used for rinsing is swallowed, get medical help or contact a Poison Control center right away.

Section 50570-1

Do not swallow.

Ionite H

NDC 53045-275-10

PERIO MAINTENANCE ANTICAVITY/ANTIGINGIVITIS RINSE

0.63 Stannous Fluoride Concentrate with Xylitol

Alcohol Free

Spearmint

IMPORTANT: Read directions for proper use.

Made in USA

Dye Free Gluten Free Paraben Free

Home Care

10 fl. oz. (296 mL)

Directions

• Do not use before mixing with water

• Adults and children 6 years of age and older:

   - Use once per day after brushing your teeth with toothpaste

   - Remove cap and replace with pump

   - Rotate spout counter clockwise to extend

   - Depress pump until rinse comes to the tip of the pump

   - Pump 1/8 fl. oz. into a cup.

   - Add water to the line (1 fl. oz.) on cup.

   - Mix using bristle end of toothbrush

   - Vigorously swish rinse between your teeth for 1 min. and then spit out.

   - Do not swallow the rinse

   - Do not eat or drink for 30 min. after rinsing

   - Instruct children under 12 in good rinsing habits to minimize swallowing.

   - Supervise children as necessary until capable of using without supervision

• Children under 6: Consult a dentist or doctor

Active Ingredient

Stannous fluoride, 0.63%

Other Information

Store at room temperature 59 – 86°F (15 – 30°C).

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.

Inactive Ingredients

Edetic acid, Flavor, Glycerin, Saccharin Sodium, Xylitol

Structured Label Content

Uses

Aids in the prevention of dental decay

Helps prevent gingivitis

Helps interfere with harmful effects of plaque associated with gingivitis

Section 42229-5 (42229-5)

Manufactured by Dharma Research, Inc.

www.dharmaresearch.com

5220 N.W. 72 Avenue, Unit 15

Miami, FL 33166

1-877-833-3725

Reorder#: 56-00135

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If more than used for rinsing is swallowed, get medical help or contact a Poison Control center right away.

Section 50570-1 (50570-1)

Do not swallow.

Purpose

Anticavity/antigingivitis

Ionite H

NDC 53045-275-10

PERIO MAINTENANCE ANTICAVITY/ANTIGINGIVITIS RINSE

0.63 Stannous Fluoride Concentrate with Xylitol

Alcohol Free

Spearmint

IMPORTANT: Read directions for proper use.

Made in USA

Dye Free Gluten Free Paraben Free

Home Care

10 fl. oz. (296 mL)

Directions

• Do not use before mixing with water

• Adults and children 6 years of age and older:

   - Use once per day after brushing your teeth with toothpaste

   - Remove cap and replace with pump

   - Rotate spout counter clockwise to extend

   - Depress pump until rinse comes to the tip of the pump

   - Pump 1/8 fl. oz. into a cup.

   - Add water to the line (1 fl. oz.) on cup.

   - Mix using bristle end of toothbrush

   - Vigorously swish rinse between your teeth for 1 min. and then spit out.

   - Do not swallow the rinse

   - Do not eat or drink for 30 min. after rinsing

   - Instruct children under 12 in good rinsing habits to minimize swallowing.

   - Supervise children as necessary until capable of using without supervision

• Children under 6: Consult a dentist or doctor

Active Ingredient

Stannous fluoride, 0.63%

Other Information

Store at room temperature 59 – 86°F (15 – 30°C).

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.

Inactive Ingredients

Edetic acid, Flavor, Glycerin, Saccharin Sodium, Xylitol

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.63", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "EDETIC ACID", "unii": "9G34HU7RV0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Aids in the prevention of dental decay Helps prevent gingivitis Helps interfere with harmful effects of plaque associated with gingivitis", "42229-5": "Manufactured by Dharma Research, Inc. www.dharmaresearch.com 5220 N.W. 72 Avenue, Unit 15 Miami, FL 33166 1-877-833-3725 Reorder#: 56-00135", "50565-1": "Keep out of reach of children under 6 years of age. If more than used for rinsing is swallowed, get medical help or contact a Poison Control center right away.", "50570-1": "Do not swallow.", "Purpose": "Anticavity/antigingivitis", "Ionite H": "NDC 53045-275-10 PERIO MAINTENANCE ANTICAVITY/ANTIGINGIVITIS RINSE 0.63 Stannous Fluoride Concentrate with Xylitol Alcohol Free Spearmint IMPORTANT: Read directions for proper use. Made in USA Dye Free Gluten Free Paraben Free Home Care 10 fl. oz. (296 mL)", "Directions": "• Do not use before mixing with water • Adults and children 6 years of age and older: - Use once per day after brushing your teeth with toothpaste - Remove cap and replace with pump - Rotate spout counter clockwise to extend - Depress pump until rinse comes to the tip of the pump - Pump 1/8 fl. oz. into a cup. - Add water to the line (1 fl. oz.) on cup. - Mix using bristle end of toothbrush - Vigorously swish rinse between your teeth for 1 min. and then spit out. - Do not swallow the rinse - Do not eat or drink for 30 min. after rinsing - Instruct children under 12 in good rinsing habits to minimize swallowing. - Supervise children as necessary until capable of using without supervision • Children under 6: Consult a dentist or doctor", "Active Ingredient": "Stannous fluoride, 0.63%", "Other Information": "Store at room temperature 59 – 86°F (15 – 30°C). 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.", "Inactive Ingredients": "Edetic acid, Flavor, Glycerin, Saccharin Sodium, Xylitol"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information