therastom

therastom
SPL v4
SPL
SPL Set ID c110cf06-98ad-b30c-e053-2995a90a8e53
Route
dental
Published
Effective Date 2021-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
cetylpyridinium (0.075 mg)
Inactive Ingredients
propylene glycol eucalyptus oil polyoxyl 40 hydrogenated castor oil water edetate calcium disodium glycerin grapefruit oil xylitol zinc gluconate peppermint oil

Identifiers & Packaging

Marketing Status
unapproved drug other active Since 2021-04-05

Purpose

Antigingivitis/Antiplaque

Description

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


Medication Information

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.

Purpose

Antigingivitis/Antiplaque

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

Inactive Ingredients

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

Description

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

Dosage

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

Use(s)

• Helps control plaque that leads to bleeding gums.

• Helps prevent gingivitis, an early form of gum disease .

Section 51945-4

Active Ingredient

Cetylpyridinium Chloride 0.075%

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.


Structured Label Content

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.

Purpose

Antigingivitis/Antiplaque

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 (Other information)

This rinse is not intended to replace brushing or flossing

Inactive Ingredients

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

Dosage

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

Use(s)

• Helps control plaque that leads to bleeding gums.

• Helps prevent gingivitis, an early form of gum disease .

Section 51945-4 (51945-4)

Active Ingredient

Cetylpyridinium Chloride 0.075%

Keep Out of Reach of Children (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.


Advanced Ingredient Data


Raw Label Data

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