WHITENING ANTICAVITY FLUORIDE TOOTH- sodium monofluorophosphate cream
Yangzhou Seeyes Fine Chemicals Co.,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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Whitening Anticavity Fluoride Toothpaste

Active Ingredient

Sodium Monofluorophosphate 0.76% (0.15% W/V fluoride ion)

Purpose

Anticavity

Use

aids in prevention of dental caries (decay)

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children under 6 years of age.

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.

Children under 6 years of age: Instruct 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 a doctor.

Inactive ingredients

calcium carbonate, FD&C blue no. 1, flavor, methyl paraben, poly ethylene glycol 400, propyl paraben, sodium carboxy methyl cellulose, sodium lauryl sulphate, sodium saccharin, sodium silicate, sorbitol, precipitated silica, tetra sodium pyrophosphate, titanium dioxide, water

Package Label

Label 1 Label 2

WHITENING ANTICAVITY FLUORIDE TOOTH
sodium monofluorophosphate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71510-040
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	76 mg in 181 g

Ingredient Name	Strength
Inactive Ingredients
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYL SALICYLATE (UNII: LAV5U5022Y)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM SILICATE (UNII: IJF18F77L3)
SORBITOL (UNII: 506T60A25R)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71510-040-00	1 in 1 BOX	07/05/2017	12/31/2018
1		181 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/05/2017	12/31/2018

Labeler - Yangzhou Seeyes Fine Chemicals Co.,Ltd (527756624)

Name	Address	ID/FEI	Business Operations
Establishment
Yangzhou Seeyes Fine Chemicals Co.,Ltd		527756624	manufacture(71510-040)

Revised: 12/2018

Document Id: 7dedab96-c18e-04f7-e053-2991aa0ac11d

Set id: ff3f17ef-5b99-4e43-b2bd-25991882447a

Version: 2

Effective Time: 20181226

Yangzhou Seeyes Fine Chemicals Co.,Ltd