WESTERN DENTAL- sodium fluoride paste

Western Dental by

Drug Labeling and Warnings

Western Dental by is a Otc medication manufactured, distributed, or labeled by Yangzhou Hongshengding Chemical Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

SODIUM MONOFLUOROPHOSPHATE 0.76%

Purpose

anticavity toothpaste

Uses

Aids in the prevention of dental cavities

Warnings

Keep out of the reach of children under 6 years of age.if more than used for brushing is accidentally swalowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

Directions

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a doctor.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing),

supervise children as necessary until capable of useing without supervision.Children under 2 years of age:consult a dentist or doctor.

INACTIVE INGREDIENT

calcium carbonate,CarboxyMethyl Cellulose ,glycerin,hydrated silica,purified water,Sodium Benzoate,Sodium Lauryl Sulfate,Sodium Saccharin,Sorbitol,Tetrasodium Diphosphate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WESTERN DENTAL 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71035-800
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
PHYTONADIOL TETRASODIUM DIPHOSPHATE (UNII: X952T8E4RN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71035-800-01	6 in 1 CARTON	02/11/2016
1		24 in 1 BOX
1		28.35 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 not final	part356	02/11/2016

Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)

Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Hongshengding Chemical Co.,Ltd.		543774755	manufacture(71035-800)