IODENT FLUORIDE REGULAR- fluoride paste
United Exchange Corp.

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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Active Ingredient Purpose

Sodium monofluorophosphate 0.76%---------------------------------------------------------------Anticavity

(Total Fluoride Content - 1000 ppm Approx.)

Uses

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

Warnings

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

In case of accidental ovedose, seek professional assistance or contact a Poison Control Center immediately.

Directions


Adults and children 2 years and older	Brush teeth thoroughly after meals, twice a day, or use as directed by a dentist or physician.
Children under 6 years	To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established.
Children under 2 years	Ask a dentist or physician.

Other information

store at room temperature 20-25°C (68-77°F)

Inactive Ingredients

calcium carbonate, water, sorbitol, hydrated silica, sodium lauryl sulfate, flavor, cellulose gum, sodium silicate, tetrasodium pyrophosphate, sodium saccharin, methylparaben, titanium dioxide, PEG-8, propylparaben, blue 1

Distributed by:

Unite Exchange Corp.

17211 Valley View Ave.,

Cerritos, CA 90703 USA

10102

IODENT FLUORIDE REGULAR
fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65923-102
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM SILICATE (UNII: IJF18F77L3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65923-102-18	1 in 1 CARTON	12/21/2016
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	10/23/2014	05/18/2021

Labeler - United Exchange Corp. (840130579)

Revised: 1/2022

Document Id: d5cca14c-7f6c-52a5-e053-2995a90ad1db

Set id: 1bd16088-dc58-4cef-9c9c-cf9e64e7ab5e

Version: 5

Effective Time: 20220117

United Exchange Corp.