Drug Labeling and Warnings

Drug Details

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3SECONDS MAGIC GARGLE LEMON- sodium fluoride mouthwash 
SUNJINBIO CO.,LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sodium Flouride

For dental care

Keep out of reach of children

1. Put one tablet in mouth.

2. Chew it.

3. Gargle for 30 sec.

4. Spit it out.

5. Rinse with water.

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.

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

For dental use only

1

3SECONDS MAGIC GARGLE LEMON 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73587-0001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 mg
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
MENTHOL (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73587-0001-118 in 1 BOX01/01/202002/01/2020
11 in 1 DOSE PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/202002/13/2020
Labeler - SUNJINBIO CO.,LTD (695626316)
Registrant - SUNJINBIO CO.,LTD (695626316)
Establishment
NameAddressID/FEIBusiness Operations
SUNJINBIO CO.,LTD695626316manufacture(73587-0001)

Revised: 2/2020
 
SUNJINBIO CO.,LTD


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