Label: IONITE H- stannous fluoride mouthwash
- NDC Code(s): 53045-276-10
- Packager: Dharma Research, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 17, 2021
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- Active Ingredient
• 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
INGREDIENTS AND APPEARANCE
stannous fluoride mouthwash
Product 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 final part355 08/03/2015 Labeler - Dharma Research, Inc. (078444642) Establishment Name Address ID/FEI Business Operations Dharma Resarch, Inc. 078444642 manufacture(53045-276)