WHITE-GLO WHITING TOOTH- sodium monofluorophosphate paste

White-Glo whiting tooth by

Drug Labeling and Warnings

White-Glo whiting tooth by is a Otc medication manufactured, distributed, or labeled by HUAIAN ZONGHENG BIO-TECH CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71167-004
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
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/02/2018

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

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