WHITE-GLO WHITING TOOTH- sodium monofluorophosphate paste
HUAIAN ZONGHENG 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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71167-004

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

WHITE-GLO WHITING TOOTH
sodium monofluorophosphate paste

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

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)