ZONSEN GEL FLUORIDE- gel fluoride toothpaste gel, dentifrice

ZONSEN Gel Fluoride by

Drug Labeling and Warnings

ZONSEN Gel Fluoride 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]

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, Carboxymethyl cellulose Sodium, Saccharin sodium,Sodium benzoate, Sorbitol, Sodium lauryl sulfate,Flavor,Silicon Dioxide, Xanthan gum

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: 72932-015-00

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

0.6 OZ. (17 g)

PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-015-01

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

0.85 OZ. (24 g)

PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-015-02

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

1.5 OZ. (43 g)

PRINCIPAL DISPLAY PANEL

ZONSEN NDC: 72932-015-03

Oral Care

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

2.75 OZ. (78 g)

INGREDIENTS AND APPEARANCE

ZONSEN GEL FLUORIDE 
gel fluoride toothpaste gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72932-015
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)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72932-015-00	17 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2025
2	NDC: 72932-015-01	24 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2025
3	NDC: 72932-015-02	43 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2025
4	NDC: 72932-015-03	78 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(72932-015)