IODENT TOOTH- sodium monofluorophosphate paste

IODENT tooth by

Drug Labeling and Warnings

IODENT tooth by is a Otc medication manufactured, distributed, or labeled by Zhaoqing Longda Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

sodium monofluorphosphate  0.76%

Purpose

Anticavity

Use

Regular brushing with fluoride toothpaste helps protect teeth and roots against cavities

Warning

Keep out of reach under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 2 years and older brush teeth thoroughly, preferably after each meal or as least twice a day , or as directly by a dentist or doctor

Children under 6 years of age 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 doctor

Inactive Ingredients

calcium carbonate , water, sorbitol , silica, polyethylene glycol 400, sodium laury alcohol, sodium carboxymethyl cellulose, flavor, sodium saccharin, methylparaben, propyparaben , sodium hydroxide

Keep out of reach of children under 6 years of age

Keep out of reach of children under 6 years of age

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IODENT TOOTH 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72129-001
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 HYDROXIDE (UNII: 55X04QC32I)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM SILICATE (UNII: IJF18F77L3)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYPERONE (UNII: HG22108KQK)
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72129-001-01	24 in 1 BOX	02/02/2018
1		6 in 1 PACKAGE
1		181 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 final	part355	02/02/2018

Labeler - Zhaoqing Longda Biotechnology Co., Ltd. (546452557)

Establishment
Name	Address	ID/FEI	Business Operations
Zhaoqing Longda Biotechnology Co., Ltd.		546452557	manufacture(72129-001)