CHARM TEX FLUORIDE GEL- sodium fluoride paste, dentifrice

Drug Labeling and Warnings

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: 42086-052
Route of Administration	DENTAL

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: 42086-052-01	1000 in 1 PACKAGE	05/31/2026
1		7.1 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 42086-052-02	720 in 1 PACKAGE	05/31/2026
2		17 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 42086-052-03	720 in 1 PACKAGE	05/31/2026
3		24 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 42086-052-04	144 in 1 PACKAGE	05/31/2026
4		43 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 42086-052-05	144 in 1 PACKAGE	05/31/2026
5		78 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 42086-052-06	60 in 1 PACKAGE	05/31/2026
6		130 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 42086-052-07	60 in 1 PACKAGE	05/31/2026
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	M017	05/31/2026

Labeler - Jiangsu Gold Worldworks Household Chemicals Co., Ltd. (527712146)

Registrant - Jiangsu Gold Worldworks Household Chemicals Co., Ltd. (527712146)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Gold Worldworks Household Chemicals Co., Ltd.		527712146	manufacture(42086-052)