CHARCOAL MINT DENTISTRY- sodium fluoride paste 
Jiangsu Shushi Biotechnology 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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73297-001 charcoal MINT dentistry

Active ingredients

Sodium Fluoride 0.24%

Purpose

anticavity

Uses

aids in the prevention of dental vavities.

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 right away.

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 doctor.

Instruct Children under 6 years of age in good burshing and rinsing ahnbits(to mininize swallowing ).supervise children as necessary until catlble of using without supervision.

Children under 2 years:Consult a dentist or doctor.

INACTIVE INGREDIENT

HYDRATED SILICA,HYDROXYETHYL CELLULOSE,WATER,CARBOXYMETHYLCELLULOSE,SACCHARIN SODIUM,SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS.SODIUM BENZOATE,SODIUM LAURYL SULFATE,SORBITOL,GLYCERIN

11

CHARCOAL MINT DENTISTRY 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73297-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
MENTHOL (UNII: L7T10EIP3A)  
Product Characteristics
ColorblackScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73297-001-0172 in 1 CARTON08/28/2019
11 in 1 BOX
1170.1 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 finalpart35608/28/2019
Labeler - Jiangsu Shushi Biotechnology Co., Ltd. (554500950)
Registrant - Jiangsu Shushi Biotechnology Co., Ltd. (543774755)
Establishment
NameAddressID/FEIBusiness Operations
Jiangsu Shushi Biotechnology Co., Ltd.554500950manufacture(73297-001)

Revised: 8/2019
Document Id: 912a6ccf-ddc5-013a-e053-2a95a90adfe3
Set id: 912a6ca0-43c8-4d9e-e053-2a95a90ac03b
Version: 1
Effective Time: 20190828
 
Jiangsu Shushi Biotechnology Co., Ltd.