PLAK SMACKER ANTI-CAVITY FLUORIDE GEL- sodium fluoride paste

PLAK SMACKER Anti-cavity Fluoride Gel by

Drug Labeling and Warnings

PLAK SMACKER Anti-cavity Fluoride Gel 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 fluoride 0.24%（0.14% w/v fluoride ion）

Purpose

Anticavitytoothpaste

Use

helps aid in the prevention of dental 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 as necessary until capable of using without supervision

Inactive Ingredients

sorbitl,water,silicon dioxide,glycerin,saccharin sodium,PEG-8,sodium carboxymethyl cellulose ,lauryl sodium sulfate,aroma,sodium benzoate,ci42090anium 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

PLAK SMACKER ANTI-CAVITY FLUORIDE GEL 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71167-005
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL, L- (UNII: 01Q0586BG1)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-8 DIOLEATE (UNII: 6JR5A7273E)
DISODIUM CARBOXYMETHYLARSONATE (UNII: T9HTL93NB7)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
AROMADENDRIN (UNII: 7YA4640575)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71167-005-01	144 in 1 CARTON	02/02/2018
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71167-005-02	120 in 1 CARTON	02/02/2018
2		24 in 1 BOX
2		28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 71167-005-04	144 in 1 CARTON	02/02/2018
3		50 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 71167-005-05	72 in 1 CARTON	02/02/2018
4		100 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 71167-005-06	144 in 1 BOX	02/02/2018
5		100 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 71167-005-03	120 in 1 CARTON	02/02/2018
6		24 in 1 BOX
6		120 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 71167-005-07	480 in 1 BOX	02/02/2018
7		28 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC: 71167-005-08	72 in 1 BOX	02/02/2018
8		120 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC: 71167-005-09	144 in 1 BOX	02/02/2018
9		120 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC: 71167-005-10	288 in 1 BOX	02/02/2018
10		50 g in 1 TUBE; Type 0: Not a Combination Product
11	NDC: 71167-005-11	480 in 1 CARTON	02/02/2018
11		24 in 1 BOX
11		28 g in 1 TUBE; Type 0: Not a Combination Product
12	NDC: 71167-005-12	576 in 1 CARTON	02/02/2018
12		144 in 1 BOX
12		24 g in 1 TUBE; Type 0: Not a Combination Product
13	NDC: 71167-005-13	72 in 1 CARTON	02/02/2018
13		12 in 1 BOX
13		120 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(71167-005)