FLUORIDE GEL- sodium fluoride paste

Fluoride Gel by

Drug Labeling and Warnings

Fluoride Gel by is a Otc medication manufactured, distributed, or labeled by Yangzhou Tracey Daily Chemical Plastic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Sodium Fluoride 0.22%(0.1 w/v Fluoride ion)

Purpose

anticavity

Uses

helps protect against cavities.

Warnings

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

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 physician.

Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years:Ask a dentist or a physician.

INACTIVE INGREDIENT

Sorbitol,Silica,methyl Paraben Sodium,Propyl Paraben Sodium ,Flavour ,Sodium Saccharin,Treated Water,SCMC,Sodium Lauryl Sulfate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLUORIDE GEL 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73343-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOCYSTEINE LYSINE MONOHYDRATE (UNII: QA5ZP9OL3E)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL PARAOXON (UNII: UE1A2XL95H)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
WATER (UNII: 059QF0KO0R)
SODIUM SILICATE (UNII: IJF18F77L3)
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73343-002-01	1 in 1 BOX	10/15/2019
1		43 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	10/14/2019

Labeler - Yangzhou Tracey Daily Chemical Plastic Co., Ltd. (560398069)

Registrant - Yangzhou Tracey Daily Chemical Plastic Co., Ltd. (560398069)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Tracey Daily Chemical Plastic Co., Ltd.		560398069	manufacture(73343-002)