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

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DRUG FACTS

Active ingredient:

Sodium Fluoride - 0.243 % (0.14 % 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, Aqua, Silica, PEG-32, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, Carbopol, Tetrasodium Pyrophosphate, Mica, FD&C Blue # 1, Titanium Dioxide

Package date and batch number on crimp.

Principal Display Panel –

Quantum Fresh kids
FLUORIDE TOOTHPASTE

Bubblegum
flavored

Quantum
a safco company

800-328-8213

www.QuantumLabs.com

Fluoride Toothpaste

Reorder #826-0002

Net Wt. 0.85 oz (24 g)

Expiration Date:
2 years from date
packed.

NDC 67239-0227-0

Made in India

C. No. DNH/COS/DNH/52

Principal Display Panel
SODIUM FLUORIDE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67239-0227
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)  
MICA (UNII: V8A1AW0880)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67239-0227-072 in 1 BOX12/24/2023
124 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02104/24/2023
Labeler - Safco Dental Supply LLC (020417380)

Revised: 10/2023
Document Id: 4819fdbd-4f57-4dcf-ae8c-24836df1612b
Set id: 788080b3-fff8-4049-af98-f571824994c2
Version: 1
Effective Time: 20231011
 
Safco Dental Supply LLC