FLUORIDE GEL- sodium fluoride paste 
Yangzhou Tracey Daily Chemical Plastic 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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Charm-Tex Fluoride Gel Toothpaste 73343-002

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

1

FLUORIDE GEL 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73343-002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73343-002-011 in 1 BOX10/15/2019
143 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/14/2019
Labeler - Yangzhou Tracey Daily Chemical Plastic Co., Ltd. (560398069)
Registrant - Yangzhou Tracey Daily Chemical Plastic Co., Ltd. (560398069)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou Tracey Daily Chemical Plastic Co., Ltd.560398069manufacture(73343-002)

Revised: 10/2019
Document Id: 94df0a78-8fd0-2d98-e053-2995a90afe14
Set id: 94df04cc-a430-c57a-e053-2995a90a7fb4
Version: 1
Effective Time: 20191014
 
Yangzhou Tracey Daily Chemical Plastic Co., Ltd.