CURODONT PROTECT- stannous fluoride paste, dentifrice

CURODONT PROTECT by

Drug Labeling and Warnings

CURODONT PROTECT by is a Otc medication manufactured, distributed, or labeled by CREDENTIS AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

STANNOUS FLUORIDE 0.454%

(0.14% W/V FLUORIDE ION)

PURPOSE

ANTICAVITY AND ANTISENSITIVITY

USE

• AIDS IN THE PREVENTION OF DENTAL CAVITIES AND BUILDS INCREASING PROTECTION AGAINST PAINFUL SENSITIVITY OF THE TEETH.

WARNINGS

Stop use and ask a doctor if

• the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
• pain/sensitivity still persists after 4 weeks of use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• Adults and children 2 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 doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
• Children under 2 years of age: Consult a dentist or doctor.

OTHER INFORMATION

This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

INACTIVE INGREDIENTS

Sorbitol, Water, Hydrated Silica, Sodium Tripolyphosphate, Sodium Gluconate, Xylitol, Cellulose Gum, Oligopeptide-104, Sodium Hydroxide, Phosphoric Acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CURODONT PROTECT 
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72247-107
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)
SODIUM GLUCONATE (UNII: R6Q3791S76)
OLIGOPEPTIDE 104 (UNII: MUM5TLH7X6)
XYLITOL (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
PHOSPHORIC ACID (UNII: E4GA8884NN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72247-107-13	1 in 1 BOX	08/27/2023
1		0.13 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 72247-107-10	10 in 1 BOX	08/27/2023
2		0.13 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/27/2023

Labeler - CREDENTIS AG (485450345)