SODIUM FLUORIDE- sodium fluoride paste, dentifrice 
Safco Dental Supply LLC

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.

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DRUG FACTS

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

Principal Display Panel – 24 g Box Label
SODIUM FLUORIDE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67239-0226
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67239-0226-024 g in 1 TUBE; Type 0: Not a Combination Product04/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/24/2023
Labeler - Safco Dental Supply LLC (020417380)

Revised: 3/2023
Document Id: d8f021a5-143a-4ba9-9a2a-f259466aefd3
Set id: 7a295974-c400-4442-9149-138a805ffb20
Version: 1
Effective Time: 20230324
 
Safco Dental Supply LLC