3SECONDS MAGIC GARGLE LEMON- sodium fluoride tablet

3SECONDS MAGIC GARGLE LEMON by

Drug Labeling and Warnings

3SECONDS MAGIC GARGLE LEMON by is a Otc medication manufactured, distributed, or labeled by SUNJINBIO CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Flouride

PURPOSE

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

1. Put one tablet in mouth.

2. Chew it.

3. Gargle for 30 sec.

4. Spit it out.

5. Rinse with water.

WARNINGS

1. The fluoride concentration of this toothpaste is 583.21 ppm.

2. Be careful not to swallow it, and rinse your mouth thoroughly after use.

3. If a child under 6 years of age swallows a large amount, consult a doctor or dentist immediately.

4. Keep out of reach of children under 6 years old.

INACTIVE INGREDIENT

MALIC ACID, HYPROMELOSE, MALTITOL, SAGE EXTRACT, XYLITOL, GREEN TEA EXTRACT, MENTHOL, MINT FLAVOR, LEMON FLAVOR, RED MINT FLAVOR, PEPPERMINT FLAVOR, ETC.

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

3SECONDS MAGIC GARGLE LEMON 
sodium fluoride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73587-0010
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.1 mg

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	14mm
Flavor	LEMON	Imprint Code	None
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73587-0010-1	18 in 1 BOX	01/01/2020
1		1 in 1 DOSE PACK; 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	01/01/2020

Labeler - SUNJINBIO CO.,LTD (695626316)

Registrant - SUNJINBIO CO.,LTD (695626316)

Establishment
Name	Address	ID/FEI	Business Operations
SUNJINBIO CO.,LTD		695626316	manufacture(73587-0010)