Label: IONITE H- stannous fluoride gel, dentifrice
- NDC Code(s): 53045-271-04
- Packager: Dharma Research, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
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
• This is not a toothpaste. Read directions carefully before using.
• Adults and children 6 years of age and older:
o Use once per day after brushing teeth thoroughly with toothpaste
o Twist off cap to remove foil seal
o Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces.
o Allow the gel to remain on your teeth for 1 minute
o Spit out. Do not swallow
o Do not eat, drink, or rinse for at least 30 minutes
• Children under 6: consult a dentist or doctors - Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Ionite H
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INGREDIENTS AND APPEARANCE
IONITE H
stannous fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53045-271 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.4 mg in 100 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53045-271-04 122 g in 1 TUBE; Type 0: Not a Combination Product 08/02/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 08/02/2015 Labeler - Dharma Research, Inc. (078444642) Establishment Name Address ID/FEI Business Operations Dharma Research, Inc. 078444642 manufacture(53045-271)