Gargle Dam by ROADLECORPORATION inc. / ECOWORLDPHARM CO .,LTD

Gargle Dam by

Drug Labeling and Warnings

Gargle Dam by is a Otc medication manufactured, distributed, or labeled by ROADLECORPORATION inc., ECOWORLDPHARM CO .,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GARGLE DAM- sodium fluoride mouthwash 
ROADLECORPORATION inc.

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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ACTIVE INGREDIENT

Sodium fluoride 0.05% in 100ml

INACTIVE INGREDIENTS

Glycerin, Carboxymethylcellulose sodium, Xylitol, Sodium Saccharin, DL-Alanine, ginseng extract, turmeric extract, Gardenia extract, Epiphyllum extract, Green tea extract, Ginger Tincture, Platycodon Root Extract, Sodium benzoate, Citric acid, Sodium citrate, acetic acid, L-Mentol

PURPOSE

Anticavity

WARNINGS

■ Keep out of reach of children.
■ Avoid direct sunlight and store in a cool place as much as possible.
■ Avoid misuse and do not replace with other containers for quality preservation.

KEEP OUT OF REACH OF CHILDREN

■ Keep out of reach of children.

Uses

■ aids in the prevention of dental cavities

Directions

■ Observe the prescribed usage, capacity.
■ When using it in children, use it under the guidance and supervision of a guardian.
■ Use this medicine only for mouthwash and do not use it for internal use or other purposes.
■ Do not use it without instructions from a pharmacist or doctor for children under the age of 6.
■ This product contains fluoride, so if you swallow a large amount, consult your dentist immediately.
■ If used by children under the age of 6, use it under the guidance of your guardian to avoid swallowing it.

Other Information

■ store at room temperature
■ cold weather may temporarily cloud this product

QUESTIONS

■ 02-522-9569

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GARGLE DAM 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82744-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82744-010-02	10 in 1 CARTON	05/01/2022	07/01/2023
1	NDC: 82744-010-01	11 mL in 1 POUCH; 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	05/01/2022	07/01/2023

Labeler - ROADLECORPORATION inc. (695387619)

Registrant - ROADLECORPORATION inc. (695387619)

Establishment
Name	Address	ID/FEI	Business Operations
ECOWORLDPHARM CO .,LTD		688735061	manufacture(82744-010)

Revised: 7/2023

Document Id: 01d407f2-12d7-faca-e063-6394a90ab864

34390-5

Set id: 11134950-00ce-4a9b-a9ea-3657e8ce7c08

Version: 3

Effective Time: 20230731