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

ADOPTAPLATOON
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71167-001
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:71167-001-01	10 g in 1 TUBE; Type 0: Not a Combination Product	01/13/2017
2	NDC:71167-001-02	25 g in 1 TUBE; Type 0: Not a Combination Product	01/13/2017
3	NDC:71167-001-03	30 g in 1 TUBE; Type 0: Not a Combination Product	01/13/2017
4	NDC:71167-001-04	24 in 1 BOX	07/10/2016
4		150 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:71167-001-05	48 in 1 BOX	07/10/2016
5		150 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC:71167-001-06	48 in 1 BOX	07/10/2016
6		150 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC:71167-001-07	288 in 1 BOX	07/10/2016
7		50 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC:71167-001-08	144 in 1 BOX	07/10/2016
8		60 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC:71167-001-09	144 in 1 BOX	07/10/2016
9		70 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC:71167-001-10	72 in 1 BOX	07/10/2016
10		85 g in 1 TUBE; Type 0: Not a Combination Product
11	NDC:71167-001-11	144 in 1 BOX	07/10/2016
11		85 g in 1 TUBE; Type 0: Not a Combination Product
12	NDC:71167-001-12	144 in 1 BOX	07/10/2016
12		100 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	07/10/2016

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

Name	Address	ID/FEI	Business Operations
Establishment
HUAIAN ZONGHENG BIO-TECH CO., LTD		527152733	manufacture(71167-001)