NUPRO FLUORIDES WILD CHERRY- sodium fluoride gel 
NUPRO FLUORIDES BUBBLE GUM- sodium fluoride gel 
Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Nupro® Fluorides
Acidulated Phosphate Fluoride (APF) Topical Gel

INDICATIONS AND USAGE

For topical application to aid in the protection against dental caries.

DOSAGE AND ADMINISTRATION

1. Remove cap from bottle, remove induction seal. DO NOT USE IF SEAL IS BROKEN.
2. Replace cap and shake well.
3. Dispense a narrow ribbon of gel into applicator trays.
4. Air dry teeth thoroughly and insert trays in mouth with head tilted slightly forward.
5. Instruct patient to continue light biting action for 1 minute (or up to 4 minutes).
A slight chewing motion enhances interproximal coverage.
6. Use suction throughout treatment.
7. Have patient expectorate after treatment.
8. Instruct patient not to eat, drink, or rinse for 30 minutes.


Recommended Frequency: Not to exceed four 4 treatments per year.

CONTRAINDICATIONS

Hypersensitivity to fluoride.

WARNINGS AND PRECAUTIONS

Do not swallow. Keep out of reach of children.
Safety and effectiveness below age 3 have not been established. There have been no long-term animal studies with this product to evaluate carcinogenic, mutagenic, or impairment of fertility potential. Laboratory studies have indicated that repeated use of APF may dull porcelain, composite restorations and sealants.

OVERDOSAGE

If treatment dose is swallowed [less than 100 mg F], administer milk, limewater, or calcium-type antacid. In case of larger doses [1 pint contains 4.5 grams F ion, which is a lethal dose], use ipecac syrup emetic and immediately seek medical help.

ADVERSE REACTIONS

Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

HOW SUPPLIED

2.59% sodium fluoride (1.23% fluoride ion) gel supplied in 12 fl. oz. bottles.

STORAGE

Store at room temperature. Protect from freezing.

SDS WARNINGS

SAFETY DATA SHEET is available on our website, www.dentsplysirona.com, or by contacting Customer Service at 1-800-989-8826.

SDS warning

MANUFACTURED FOR

Manufactured For:
DENTSPLY Professional
1301 Smile Way
York, PA 17404 USA
1-800-989-8826

Made in the U.S.A

PRINCIPAL DISPLAY PANEL - Wild Cherry

wild cherry

PRICIPAL DISPLAY PANEL - Bubble Gum

bubble gum

NUPRO FLUORIDES  WILD CHERRY
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65222-431
Route of Administration DENTAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 25.9 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
HYDROFLUORIC ACID (UNII: RGL5YE86CZ)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Color red Score     
Shape Size
Flavor CHERRY (Wild Cherry) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65222-431-44 7 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/1900
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/1900
NUPRO FLUORIDES  BUBBLE GUM
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65222-451
Route of Administration DENTAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 25.9 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
HYDROFLUORIC ACID (UNII: RGL5YE86CZ)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Color pink Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65222-451-44 7 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/1900
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/1900
Labeler - Dentsply LLC. Professional Division Trading as "DENTSPLY Professional" (144140845)
Establishment
Name Address ID/FEI Business Operations
Dentsply Caulk 083235549 manufacture(65222-431, 65222-451)

Revised: 11/2017
Document Id: 6154542f-4ea5-7155-e053-2991aa0ad998
Set id: 6154542f-4ea4-7155-e053-2991aa0ad998
Version: 1
Effective Time: 20171127
 
Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"