WHITE-GLO 2IN1 WITH MOUTHWASH- sodium monofluorophosphate paste

White-Glo 2in1 with mouthwash by

Drug Labeling and Warnings

White-Glo 2in1 with mouthwash 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,denature alcohol(2.5%),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 2IN1 WITH MOUTHWASH 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71167-002
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)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71167-002-01	24 in 1 BOX	07/10/2016
1		150 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71167-002-02	48 in 1 BOX	07/10/2016
2		150 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	07/10/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
HUAIAN ZONGHENG BIO-TECH CO., LTD		527152733	manufacture(71167-002)