CURODONT PROTECT- stannous fluoride paste, dentifrice 
CREDENTIS AG

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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CREDENTIS (as PLD) - vVardis Professional - CURODONT PROTECT (72247-107)

ACTIVE INGREDIENTS

STANNOUS FLUORIDE 0.454%

(0.14% W/V FLUORIDE ION)

PURPOSE

ANTICAVITY AND ANTISENSITIVITY

USE

WARNINGS

Stop use and ask a doctor if

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

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.

PDP

DF

CURODONT PROTECT 
stannous fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72247-107
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72247-107-131 in 1 BOX08/27/2023
10.13 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:72247-107-1010 in 1 BOX08/27/2023
20.13 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/27/2023
Labeler - CREDENTIS AG (485450345)

Revised: 8/2023
Document Id: 04377fa2-7d06-503b-e063-6394a90a0a42
Set id: 03ec591c-68c3-a380-e063-6394a90a131a
Version: 2
Effective Time: 20230831
 
CREDENTIS AG