White-Glo Whiting Tooth (Sodium Monofluorophosphate) Paste [Huaian Zongheng Bio-Tech Co., Ltd] -

WHITE-GLO WHITING TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE [HUAIAN ZONGHENG BIO-TECH CO., LTD]
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NDC	71167-004-01, 71167-004-02, 71167-004-03, 71167-004-04, 71167-004-05, 71167-004-06, 71167-004-07, 71167-004-08, 71167-004-09, 71167-004-10
Set ID	64384dff-e2c6-2f96-e053-2a91aa0a9a5d
Category	HUMAN OTC DRUG LABEL
Packager	HUAIAN ZONGHENG BIO-TECH CO., LTD
Generic Name
Product Class
Product Number
Application Number	PART355

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Active Ingredient

sodium monofluorphosphate 0.76%
Purpose

Anticavitytoothpaste
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 right away.
Directions

Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist.

do not swallow

to minimize swallowing use a pea-sized amount in children under 6

supervise children's burshing ntil good habits are established

children under 2 years ask a dentist
Inactive Ingredients

Calcium Carbonate,Aqua,Glycerin,Sorbitol,Silica,Aroma,Sodium Lauryl Sulphate,Carboxymethyl Hydroxyethyl cellulose,Chondrus Crispus,CI77891(Titanium Dioxide),Sodium saccharin,rose canina fruit oil
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

WHITE-GLO WHITING TOOTH
sodium monofluorophosphate paste

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
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITOL (UNII: 506T60A25R)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)
ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71167-004-01	24 in 1 BOX	02/02/2018
1		150 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:71167-004-02	48 in 1 BOX	02/02/2018
2		150 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:71167-004-03	24 in 1 BOX	02/02/2018
3		100 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:71167-004-04	48 in 1 BOX	02/02/2018
4		100 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:71167-004-05	20 in 1 BOX	02/02/2018
5		80 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC:71167-004-06	40 in 1 BOX	02/02/2018
6		80 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC:71167-004-07	144 in 1 BOX	02/02/2018
7		50 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC:71167-004-08	100 in 1 BOX	02/02/2018
8		24 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC:71167-004-09	188 in 1 BOX	02/02/2018
9		24 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC:71167-004-10	1000 in 1 BOX	02/02/2018
10		12 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 final	part355	02/02/2018

Labeler - HUAIAN ZONGHENG BIO-TECH CO., LTD (527152733)

Name	Address	ID/FEI	Business Operations
Establishment
HUAIAN ZONGHENG BIO-TECH CO., LTD		527152733	manufacture(71167-004)

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Medic