CHARM TEX FLUORIDE- 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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FLUORIDE TOOTHPASTE 73343-003

Active Ingredient

Sodium Fluoride 0.76%(0.1%w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warning

Keep out of 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.

Directions

Adults and children 6 years 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 to 6:Use only a pea sized amount and supervise child’s brushing and rinsing to minimize swallowing.
Children under 2:Ask dentist or physician

Inactive Ingredients

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

Keep out of reach of children under 6 years of age

Keep out of reach of children under 6 years of age

1

CHARM TEX FLUORIDE 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73343-003
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73343-003-0178 g in 1 TUBE; Type 0: Not a Combination Product10/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/15/2019
Labeler - Yangzhou Tracey Daily Chemical Plastic Co., Ltd. (560398069)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou Tracey Daily Chemical Plastic Co., Ltd.560398069manufacture(73343-003)

Revised: 10/2019
Document Id: 94ea3d85-fc70-cd67-e053-2a95a90abeda
Set id: 94ea4704-b476-1994-e053-2995a90afe9a
Version: 1
Effective Time: 20191014
 
Yangzhou Tracey Daily Chemical Plastic Co., Ltd.