THERASTOM- antigingivitis/antiplaque mouth rinse rinse

TheraStom by

Drug Labeling and Warnings

TheraStom by is a Otc medication manufactured, distributed, or labeled by Forward Science Technologies LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactive Ingredients

Calcium Disodium EDTA, Flavor (Peppermint, Eucalyptus, Pink Grapefruit), Glycerin, PEG-40, Propylene Glycol, Water, Xylitol, Zinc Gluconate

Active Ingredient

Cetylpyridinium Chloride 0.075%

Purpose

Antigingivitis/Antiplaque

Use(s)

Helps control plaque that leads to bleeding gums.
Helps prevent gingivitis, an early form of gum disease .

Warnings

Stop use and ask a dentist if:
Gingivitis, bleeding, or redness persists for more than 2 weeks
You have painful or swollen gums, pus from the gum line, loose teeth, or increased spacing between the teeth.
These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of reach of children

Keep out of reach of children under 6 years of age.
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years or older: Vigorously swish 20 ml (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
Children 6 years to under 12 years of age: supervise use
Children under 6 years of age: do not use

Other information

This rinse is not intended to replace brushing or flossing

Dosage

Vigorously swish 20 ml (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERASTOM 
antigingivitis/antiplaque mouth rinse rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70275-936
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.075 mg  in 0.1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EUCALYPTUS OIL (UNII: 2R04ONI662)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
GLYCERIN (UNII: PDC6A3C0OX)
GRAPEFRUIT OIL (UNII: YR377U58W9)
XYLITOL (UNII: VCQ006KQ1E)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70275-936-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/05/2021

Labeler - Forward Science Technologies LLC (079212068)

Establishment
Name	Address	ID/FEI	Business Operations
Forward Science Technologies LLC		079212068	manufacture(70275-936)