CHARM-TEX FLUORIDE GEL- sodium fluoride paste, dentifrice 
Jiangsu Aimeili Cosmetic Co.,Ltd.

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77573-012

Active ingredients

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

Purpose

Anticavity

Uses

Help 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

INACTIVE INGREDIENT

Sorbitol, Silica, Calcium Carbonate, Methylparaben Sodium, Propylparaben Sodium, Flavor, Sodium Saccharin, Water,  SCMC, Sodium Lauryl Sulfate

image description

CHARM-TEX FLUORIDE GEL 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77573-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77573-012-011000 in 1 PACKAGE07/11/2022
17.1 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:77573-012-02720 in 1 PACKAGE07/11/2022
217 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:77573-012-03720 in 1 PACKAGE07/11/2022
324 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:77573-012-04144 in 1 PACKAGE07/11/2022
443 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:77573-012-05144 in 1 PACKAGE07/11/2022
578 g in 1 TUBE; Type 0: Not a Combination Product
6NDC:77573-012-0660 in 1 PACKAGE07/11/2022
6130 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:77573-012-0760 in 1 PACKAGE07/11/2022
7181 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02107/10/2022
Labeler - Jiangsu Aimeili Cosmetic Co.,Ltd. (543903077)
Registrant - Jiangsu Aimeili Cosmetic Co.,Ltd. (543903077)
Establishment
NameAddressID/FEIBusiness Operations
Jiangsu Aimeili Cosmetic Co.,Ltd.543903077manufacture(77573-012)

Revised: 1/2024
Document Id: 0e2cfc15-6059-76aa-e063-6394a90a9bf1
Set id: fa04010f-6c5c-4921-a1f7-e1770e9aef12
Version: 2
Effective Time: 20240105
 
Jiangsu Aimeili Cosmetic Co.,Ltd.