CHARM-TEX FLUORIDE GEL- sodium fluoride paste, dentifrice

Charm-Tex FLUORIDE Gel by

Drug Labeling and Warnings

Charm-Tex FLUORIDE Gel by is a Otc medication manufactured, distributed, or labeled by Jiangsu Aimeili Cosmetic Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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 years: Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowing
• Children under 2 years: Ask a dentist or physician

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHARM-TEX FLUORIDE GEL 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77573-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77573-012-01	1000 in 1 PACKAGE	07/11/2022
1		7.1 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 77573-012-02	720 in 1 PACKAGE	07/11/2022
2		17 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 77573-012-03	720 in 1 PACKAGE	07/11/2022
3		24 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 77573-012-04	144 in 1 PACKAGE	07/11/2022
4		43 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 77573-012-05	144 in 1 PACKAGE	07/11/2022
5		78 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 77573-012-06	60 in 1 PACKAGE	07/11/2022
6		130 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 77573-012-07	60 in 1 PACKAGE	07/11/2022
7		181 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/10/2022

Labeler - Jiangsu Aimeili Cosmetic Co.,Ltd. (543903077)

Registrant - Jiangsu Aimeili Cosmetic Co.,Ltd. (543903077)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Aimeili Cosmetic Co.,Ltd.		543903077	manufacture(77573-012)