Tayadent With Fluoride by COSMOPHARM LTD. / Emilia Cosmetics Ltd Tayadent With Fluoride

Tayadent With Fluoride by

Drug Labeling and Warnings

Tayadent With Fluoride by is a Otc medication manufactured, distributed, or labeled by COSMOPHARM LTD., Emilia Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

TAYADENT WITH FLUORIDE 
sodium monofluorophosphate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69939-291
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69939-291-03	150 g in 1 BOTTLE; Type 0: Not a Combination Product	02/04/2016	09/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/04/2016	09/01/2019

Labeler - COSMOPHARM LTD. (600395487)

Establishment
Name	Address	ID/FEI	Business Operations
Emilia Cosmetics Ltd		600076624	manufacture(69939-291)

Revised: 8/2019

Document Id: 90b48bfc-2595-792d-e053-2995a90a2945

34390-5

Set id: 70857412-8789-4045-baaf-62d1342a2ef9

Version: 3

Effective Time: 20190822

 

COSMOPHARM LTD.