ZONSEN TOOTHPASTE,WHITE- toothpaste paste, dentifrice

ZONSEN Toothpaste,white by

Drug Labeling and Warnings

ZONSEN Toothpaste,white by is a Otc medication manufactured, distributed, or labeled by Wuhan Zonsen Medical Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ZONSEN Fluoride Toothpaste

ACTIVE INGREDIENT

Sodium Fluoride 0.22%

PURPOSE

Anticavity

INDICATIONS & USAGE

Aids in the prevention of dental cavities.

WARNINGS

Keep out of the 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 immediately.

DOSAGE & ADMINISTRATION

Do not swallow, supervise children as necessary until capable of using without supervision. Instruct Children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: Do not use unless directed by a doctor or dentist.

INACTIVE INGREDIENT

Water, Calcium carbonate, Silicon Dioxide, Carboxymethyl cellulose Sodium,Guaraprolose, Saccharin sodium, Sodium benzoate, Sorbitol, Sodium lauryl sulfate, flavor

KEEP OUT OF REACH OF CHILDREN

Keep out of the 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 immediately.

PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-016-00

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

0.6 OZ. (17 g)

PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-016-01

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

0.85 OZ. (24 g)

PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-016-02

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

1.5 OZ. (43 g)

PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-016-03

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

2.75 OZ. (78 g)

PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-016-04

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

4.75 OZ. (134 g)

PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-016-05

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

6.4 OZ. (181 g)

INGREDIENTS AND APPEARANCE

ZONSEN TOOTHPASTE,WHITE 
toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72932-016
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GUARAPROLOSE (1300 MPA.S AT 1%) (UNII: 1530WMS90S)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72932-016-00	17 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2025
2	NDC: 72932-016-01	24 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2025
3	NDC: 72932-016-02	43 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2025
4	NDC: 72932-016-03	78 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2025
5	NDC: 72932-016-04	134 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2025
6	NDC: 72932-016-05	181 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	02/11/2025

Labeler - Wuhan Zonsen Medical Products Co., Ltd. (554474517)

Registrant - Wuhan Zonsen Medical Products Co., Ltd. (554474517)

Establishment
Name	Address	ID/FEI	Business Operations
Wuhan Zonsen Medical Products Co., Ltd.		554474517	manufacture(72932-016)