Label: IONITE H- stannous fluoride gel, dentifrice
- NDC Code(s): 53045-270-04
- 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 August 2, 2015
If you are a consumer or patient please visit this version.
- Active Ingredient
Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
• 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 doctor
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Ionite H
INGREDIENTS AND APPEARANCE
stannous fluoride gel, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53045-270 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 SPEARMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53045-270-04 122 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 final part355 08/02/2015 Labeler - Dharma Research, Inc. (078444642) Establishment Name Address ID/FEI Business Operations Dharma Research, Inc. 078444642 manufacture(53045-270)