CHARM TEX FLUORIDE- sodium fluoride paste 
Yangzhou Hongshengding Chemical 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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TOOTHPASTE DRUG FACTS

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:71035-200
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:71035-200-0117 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
2NDC:71035-200-0224 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
3NDC:71035-200-0335 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
4NDC:71035-200-0443 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
5NDC:71035-200-0550 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
6NDC:71035-200-0670 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
7NDC:71035-200-0778 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
8NDC:71035-200-0890 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
9NDC:71035-200-09100 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
10NDC:71035-200-10120 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
11NDC:71035-200-11130 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
12NDC:71035-200-12150 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
13NDC:71035-200-13180 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
14NDC:71035-200-143 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
15NDC:71035-200-155 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
16NDC:71035-200-1610 g in 1 TUBE; Type 0: Not a Combination Product10/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/20/2016
Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou Hongshengding Chemical Co.,Ltd.543774755manufacture(71035-200)

Revised: 1/2018
Document Id: 62175f7d-6bea-2fb8-e053-2991aa0adb4b
Set id: 3f4d3a9f-b320-3f8e-e054-00144ff88e88
Version: 2
Effective Time: 20180106
 
Yangzhou Hongshengding Chemical Co.,Ltd.