THERASTOM- antigingivitis/antiplaque mouth rinse rinse
Forward Science Technologies LLC

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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TheraStom

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.

therastombottlelabel

THERASTOM
antigingivitis/antiplaque mouth rinse rinse

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

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

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

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

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

Labeler - Forward Science Technologies LLC (079212068)

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

Revised: 4/2021

Document Id: c110cf06-98ae-b30c-e053-2995a90a8e53

Set id: c110cf06-98ad-b30c-e053-2995a90a8e53

Version: 1

Effective Time: 20210405

Forward Science Technologies LLC