Label: FRESHMINT ANTICAVITY FLUORIDE- sodium fluoride gel, dentifrice
view more51824-068-05, 51824-068-06, 51824-068-07
- Packager: New World Imports, 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 November 1, 2018
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- ACTIVE INGREDIENT
Sodium Fluoride - 0.22% (0.1% w/v fluoride ion)Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.Close
- INDICATIONS & USAGE
Helps protect against cavitiesClose
Keep out of reach of children.Close
- DOSAGE & ADMINISTRATION
Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each mean or at least twice a day, or as directed by a dentist or physician.
Children 2 to 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 physicianClose
- INACTIVE INGREDIENT
Treated Water, Sorbitol, Carbopol, Sodium Lauryl Sulphate, Flavor, Polyethylene Glycol 1500, Sodium Saccharin, Precipiated Silica, Sodium Carboxy Methyl Cellulose, Methylparaben, Propylparaben.Close
- INGREDIENTS AND APPEARANCE
FRESHMINT ANTICAVITY FLUORIDE
sodium fluoride gel, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-068 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 2.2 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) Sodium Lauryl Sulfate (UNII: 368GB5141J) Polyethylene Glycol 1500 (UNII: 1212Z7S33A) Saccharin Sodium (UNII: SB8ZUX40TY) Silicon Dioxide (UNII: ETJ7Z6XBU4) Carboxymethylcellulose Sodium (UNII: K679OBS311) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Product Characteristics Color Score Shape Size Flavor MINT (Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-068-01 7.9 g in 1 PACKET; Type 0: Not a Combination Product 09/17/2010 2 NDC:51824-068-02 17 g in 1 TUBE; Type 0: Not a Combination Product 09/17/2010 3 NDC:51824-068-03 24 g in 1 TUBE; Type 0: Not a Combination Product 09/17/2010 4 NDC:51824-068-04 43 g in 1 TUBE; Type 0: Not a Combination Product 09/17/2010 5 NDC:51824-068-05 78 g in 1 TUBE; Type 0: Not a Combination Product 09/17/2010 6 NDC:51824-068-06 130 g in 1 TUBE; Type 0: Not a Combination Product 09/17/2010 7 NDC:51824-068-07 181 g in 1 TUBE; Type 0: Not a Combination Product 09/17/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/17/2010 Labeler - New World Imports, Inc (075372276)