FLUORIDE GEL- sodium fluoride paste
Yangzhou Hongshengding Chemical 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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Charm-Tex Fluoride Gel Toothpaste

Active ingredients

Sodium Fluoride 0.22%(0.15 w/v Fluoride ion)

Purpose

anticavity

Uses

helps 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 2years 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 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years:Ask a dentist or a physician.

INACTIVE INGREDIENT

Sorbitol,Silica,methyl Paraben Sodium,Propyl Paraben Sodium ,Flavour ,Sodium Saccharin,Treated Water,SCMC,Sodium Lauryl Sulfate

FLUORIDE GEL
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71035-400
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CARBOCYSTEINE LYSINE MONOHYDRATE (UNII: QA5ZP9OL3E)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL PARAOXON (UNII: UE1A2XL95H)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
WATER (UNII: 059QF0KO0R)
SODIUM SILICATE (UNII: IJF18F77L3)
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71035-400-01	720 in 1 BOX	05/25/2016
1		17 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:71035-400-02	720 in 1 BOX	05/25/2016
2		24 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:71035-400-03	144 in 1 BOX	03/07/2016
3		43 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:71035-400-04	1000 in 1 BOX	05/01/2015
4		0.22 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:71035-400-05	1000 in 1 BOX	05/01/2015
5		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	05/01/2015

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Yangzhou Hongshengding Chemical Co.,Ltd.		543774755	manufacture(71035-400)