NUPRO FLUORIDES WILD CHERRY- sodium fluoride gel NUPRO FLUORIDES BUBBLE GUM- sodium fluoride gel

Nupro Fluorides by

Drug Labeling and Warnings

Nupro Fluorides by is a Prescription medication manufactured, distributed, or labeled by Dentsply LLC. Professional Division Trading as "DENTSPLY Professional", Dentsply Caulk. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

PRICIPAL DISPLAY PANEL - Bubble Gum

INGREDIENTS AND APPEARANCE

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)