Label: IONITE H- stannous fluoride mouthwash
- NDC Code(s): 53045-276-10
- Packager: Dharma Research, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 11, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
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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
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Ionite H
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INGREDIENTS AND APPEARANCE
IONITE H
stannous fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53045-276 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.63 mg in 100 mL Inactive Ingredients Ingredient Name Strength EDETIC ACID (UNII: 9G34HU7RV0) GLYCERIN (UNII: PDC6A3C0OX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor FRUIT PUNCH Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53045-276-10 269 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 08/03/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 08/03/2015 Labeler - Dharma Research, Inc. (078444642) Establishment Name Address ID/FEI Business Operations Dharma Resarch, Inc. 078444642 manufacture(53045-276)