TEETH DESENSITIZING AND REMINERALIZING GEL- potassium nitrate,sodium fluoride,sodium monofluorophosphate paste
Fuzhou Difeng Bio-tech 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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teeth desensitizing and remineralizing gel 49410-200

Active ingredients

Potassium nitrate 5%
Sodium Fluoride 0.15%

Purpose

.antihypersensitivity
.anticavity

Uses

To relieve the discomfort from teeth sensitivity caused by thermal, chemical changes, periodontal
conditions...etc. Aids in the prevention of dental cavities.

Warnings

Do not swallow. Avoid contact with eyes. Discontinue use and consultant your dentist if allegric
reaction or gum irritation occurs.

Keep out of reach of children.

Directions

Adults and children 18 years of age and older: Directly apply 1ml-1.5ml of the product on
sensitive teeth, or use it in a custom mouth tray. Keep your mouth open for 10-15 mins. Then rinse
your month to clean the gel. Use it 1-2 times daily or as recommended by a dentist or physician.
Children under 18 years of age and pregnant, breast feeding women: consult a dentist or
physician prior to use.

INACTIVE INGREDIENT

Carbopol, Deionized Water, Glycerin, Menthol, Sodium Saccharine,SODIUM MONOFLUOROPHOSPHATE

TEETH DESENSITIZING AND REMINERALIZING GEL
potassium nitrate,sodium fluoride,sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49410-200
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q)
MENTHOL (UNII: L7T10EIP3A)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49410-200-01	5 in 1 CARTON	01/08/2018
1		200 in 1 CONTAINER
1		1.5 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC:49410-200-02	5 in 1 CARTON	01/08/2018
2		100 in 1 CONTAINER
2		2 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
3	NDC:49410-200-03	5 in 1 CARTON	01/08/2018
3		100 in 1 CONTAINER
3		4 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
4	NDC:49410-200-04	5 in 1 CARTON	01/08/2018
4		80 in 1 CONTAINER
4		6 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
5	NDC:49410-200-05	6 in 1 CARTON	01/08/2018
5		300 in 1 CONTAINER
5		4.5 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
6	NDC:49410-200-06	6 in 1 CARTON	01/08/2018
6		200 in 1 CONTAINER
6		10 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
7	NDC:49410-200-07	6 in 1 CARTON	01/08/2018
7		333 in 1 CONTAINER
7		3 g in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
8	NDC:49410-200-08	300 in 1 CARTON	01/08/2018
8		3.5 g in 1 VIAL, SINGLE-USE; 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	03/07/2016

Labeler - Fuzhou Difeng Bio-tech Co., Ltd. (528195950)

Registrant - Fuzhou Difeng Bio-tech Co., Ltd. (528195950)

Name	Address	ID/FEI	Business Operations
Establishment
Fuzhou Difeng Bio-tech Co., Ltd.		528195950	manufacture(49410-200)