Ionite H Mouthwash
FDA Label NDC 53045-276

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dharma Research, Inc. for the product Ionite H (NDC 53045-276). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, otc - keep out of reach of children, otc - do not use, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Stannous Fluoride, 0.63%

Purpose

Anticavity/Antigingivitis

Uses

  • Aids in the prevention of dental decay
    • Helps prevent gingivitis
      • Helps interfere with harmful effects of plaque associated with gingivitis

Otc - Keep Out Of Reach Of Children

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.

Otc - Do Not Use

Do not swallow.

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

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

Other

Manufactured by Dharma Research, Inc.

www.dharmaresearch.com

5220 N.W. 72 Avenue, Unit 15

Miami, FL 33166

1-877-833-3725

Reorder#: 56-00136

Ionite H

NDC 53045-276-10

PERIO MAINTENANCE ANTICAVITY/ANTIGINGIVITIS RINSE

0.63 Stannous Fluoride Concentrate with Xylitol

Alcohol Free

Fruit Punch

IMPORTANT: Read directions for proper use.

Made in USA

Dye Free Gluten Free Paraben Free

Home Care

10 fl. oz. (296 mL)

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