GRAY SALT- sodium fluoride mouthwash

Gray Salt by

Drug Labeling and Warnings

Gray Salt by is a Otc medication manufactured, distributed, or labeled by DONG IL PHARMS CO.,LTD, DONG IL PHARMS 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

Put an appropriate amount (10-15mL) in your mouth, gargle for 30 seconds, spit out, and brush your teeth by brushing.

WARNINGS

1. The fluoride concentration of this toothpaste is 363.33 ppm.
2. Be careful not to swallow it, and rinse your mouth thoroughly after use.
3. If this toothpaste causes any abnormalities such as gum or mouth damage, discontinue use and consult a doctor or dentist.
4. For children under 6 years of age, use a small amount of pea toothpaste per serving and use it under the supervision of a guardian to avoid sucking or swallowing.
5. If a child under 6 years of age swallows a large amount, consult a doctor or dentist immediately.
6. Keep out of reach of children under 6 years old.

INACTIVE INGREDIENT

Chamomile Extract
Sage Extract
Aloe Extract
Eucalyptus Extract
Concentrated Glycerin
Polyethylene Glycol 1500
Polysorbate 20
Sodium Chloride
Xylitol
L-Menthol
Peppermint Oil
Ethanol
Water

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GRAY SALT 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73242-0030
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.08 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73242-0030-1	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/01/2019

Labeler - DONG IL PHARMS CO.,LTD (557810721)

Registrant - DONG IL PHARMS CO.,LTD (557810721)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(73242-0030)