Label: SODIUM FLUORIDE paste, dentifrice
- NDC Code(s): 67239-0227-0
- Packager: Safco Dental Supply LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 11, 2023
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- Active ingredient:
- Purpose:
- Use:
- Warning:
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Directions:
Adults and Children 6-years 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 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 a physician
- Other ingredients:
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INGREDIENTS AND APPEARANCE
SODIUM FLUORIDE
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67239-0227 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 2.43 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CARRAGEENAN (UNII: 5C69YCD2YJ) XANTHAN GUM (UNII: TTV12P4NEE) BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD) SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM BENZOATE (UNII: OJ245FE5EU) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) BENZYL ALCOHOL (UNII: LKG8494WBH) TRICLOSAN (UNII: 4NM5039Y5X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MICA (UNII: V8A1AW0880) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67239-0227-0 72 in 1 BOX 12/24/2023 1 24 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 Drug M021 04/24/2023 Labeler - Safco Dental Supply LLC (020417380)