Label: FLUORIDE GEL- sodium fluoride paste
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Contains inactivated NDC Code(s)
NDC Code(s): 73343-002-01 - Packager: Yangzhou Tracey Daily Chemical Plastic Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Drug Label Information
Updated October 14, 2019
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- Active ingredients
- Uses
- Warnings
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Directions
Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.
Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
Children under 2 years:Ask a dentist or a physician.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLUORIDE GEL
sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73343-002 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.22 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOCYSTEINE LYSINE MONOHYDRATE (UNII: QA5ZP9OL3E) SORBITOL (UNII: 506T60A25R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) METHYL PARAOXON (UNII: UE1A2XL95H) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) WATER (UNII: 059QF0KO0R) SODIUM SILICATE (UNII: IJF18F77L3) POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73343-002-01 1 in 1 BOX 10/15/2019 1 43 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/14/2019 Labeler - Yangzhou Tracey Daily Chemical Plastic Co., Ltd. (560398069) Registrant - Yangzhou Tracey Daily Chemical Plastic Co., Ltd. (560398069) Establishment Name Address ID/FEI Business Operations Yangzhou Tracey Daily Chemical Plastic Co., Ltd. 560398069 manufacture(73343-002)