SODIUM FLUORIDE paste, dentifrice

Sodium Fluoride by

Drug Labeling and Warnings

Sodium Fluoride by is a Otc medication manufactured, distributed, or labeled by Safco Dental Supply LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient:

Sodium fluoride - 0.243% (0.15% w/v Fluoride ion)

Purpose:

Anti-cavity

Use:

Helps protect against cavities

Warning:

KEEP OUT OF THE REACH OF CHILDREN UNDER 6 YEARS OF AGE. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

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:

Sorbitol, Silica, Treated Water, Poly Ethylene Glycol 1500, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose gum and/or Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Tetra Sodium Pyrophosphate, Glycerin, Color: FD&C Blue #1

Package date and batch number on crimp.

Principal Display Panel – 24 g Box Label

Quantum Fresh
FLUORIDE TOOTHPASTE

Quantum

a safco company

800-328-8213

www.QuantumLabs.com

Fluoride Toothpaste

Reorder # 826-0001

Net Wt. 0.85 oz (24 g)

Expiration Date:

2 years from date
packed.

NDC: 67239-0226-0

Made in India

INGREDIENTS AND APPEARANCE

SODIUM FLUORIDE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67239-0226
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67239-0226-0	24 g in 1 TUBE; Type 0: Not a Combination Product	04/24/2023

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)