CHARM TEX FLUORIDE- sodium fluoride paste

Charm Tex Fluoride by

Drug Labeling and Warnings

Charm Tex Fluoride by is a Otc medication manufactured, distributed, or labeled by Yangzhou Hongshengding Chemical Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHARM TEX FLUORIDE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71035-200
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71035-200-01	17 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
2	NDC: 71035-200-02	24 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
3	NDC: 71035-200-03	35 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
4	NDC: 71035-200-04	43 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
5	NDC: 71035-200-05	50 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
6	NDC: 71035-200-06	70 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
7	NDC: 71035-200-07	78 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
8	NDC: 71035-200-08	90 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
9	NDC: 71035-200-09	100 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
10	NDC: 71035-200-10	120 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
11	NDC: 71035-200-11	130 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
12	NDC: 71035-200-12	150 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
13	NDC: 71035-200-13	180 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
14	NDC: 71035-200-14	3 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
15	NDC: 71035-200-15	5 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016
16	NDC: 71035-200-16	10 g in 1 TUBE; Type 0: Not a Combination Product	10/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/20/2016

Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Hongshengding Chemical Co.,Ltd.		543774755	manufacture(71035-200)