TAYADENT WITH FLUORIDE- sodium monofluorophosphate liquid 
COSMOPHARM LTD.

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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Tayadent With Fluoride

ACTIVE INGREDIENTS


Sodium Monofluorophosphate 0.4% (0.06% Fluoride Ion)


Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, get medical help or contact a poison control center immediately.

Do not use

if you have known sensitivities to any one of the ingredient

When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

This product should be used only for the purpose for which it was intended and according to its instructions.

Do not ingest.

Directions

  • Adults and children 6 years of age and older. Dilute in a little mouthwash half a glass of water or drip a little on a damp toothbrush. do not swallow the rinse
  • instruct children under 12 years of age in good rising habits (to minimize swallowing) supervise children as necessary until capable of  using without supervision
  • Children under 6 years ask a dentist or physician

Inactive ingredients

Water, Sodium Lauryl Sulfate, Flavour, Propylene Glycol, Sodium Saccharin, Sodium Methylparaben, Citric Acid, Sodium Propylparaben, Eugrnol, Linalool, Limonene

Other information

Do not use if safety seal is broken or missing

Questions?

Call (845) 501-0127

Principal Display Panel

TAYADENT Mouthwash

With Fluoride

Cleans and helps to prevent

cavities and plaque

Alcohol-free

Freshens Breath

Economy Size - 20% Free

nt wt 5.07 fl oz 150 ml (150 gr)

NDC 69939-291-03

Label

TAYADENT WITH FLUORIDE 
sodium monofluorophosphate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69939-291
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EUGENOL (UNII: 3T8H1794QW)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69939-291-03150 g in 1 BOTTLE; Type 0: Not a Combination Product02/04/201609/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/04/201609/01/2019
Labeler - COSMOPHARM LTD. (600395487)
Establishment
NameAddressID/FEIBusiness Operations
Emilia Cosmetics Ltd600076624manufacture(69939-291)

Revised: 8/2019
Document Id: 90b48bfc-2595-792d-e053-2995a90a2945
Set id: 70857412-8789-4045-baaf-62d1342a2ef9
Version: 3
Effective Time: 20190822
 
COSMOPHARM LTD.