CHARM TEX FLUORIDE- sodium fluoride paste
Yangzhou Hengyuan Daily Chemical Plastic 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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TOOTHPASTE DRUG FACTS

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

label

CHARM TEX FLUORIDE
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51289-200
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:51289-200-01	17 g in 1 TUBE
2	NDC:51289-200-02	24 g in 1 TUBE
3	NDC:51289-200-03	35 g in 1 TUBE
4	NDC:51289-200-04	43 g in 1 TUBE
5	NDC:51289-200-05	50 g in 1 TUBE
6	NDC:51289-200-06	70 g in 1 TUBE
7	NDC:51289-200-07	78 g in 1 TUBE
8	NDC:51289-200-08	90 g in 1 TUBE
9	NDC:51289-200-09	100 g in 1 TUBE
10	NDC:51289-200-10	120 g in 1 TUBE
11	NDC:51289-200-11	130 g in 1 TUBE
12	NDC:51289-200-12	150 g in 1 TUBE
13	NDC:51289-200-13	180 g in 1 TUBE
14	NDC:51289-200-14	3 g in 1 TUBE
15	NDC:51289-200-15	5 g in 1 TUBE
16	NDC:51289-200-16	10 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	07/10/2013

Labeler - Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. (527127383)

Name	Address	ID/FEI	Business Operations
Establishment
Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.		527127383	manufacture(51289-200)