Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c8529d7a-f93c-9bba-e053-2995a90a9fea
Route
DENTAL
Published
Effective Date 2021-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.02 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-07-30

Description

sodium fluoride


Medication Information

Warnings and Precautions

Keep out of reach of children under 6 years of age.

Do not swallow

If accidentally swallowed, get medical help or contact Poison Control Center right away.

Indications and Usage

- Adults and children 6 years of age and older:

Rinse for 60 secondswith 10ml (2 teaspoonful) and then spit out

Do not swallow the rinse

Supervise children as necessary until capable of using without supervision

- Children under 6

Consult a dentist or physician

Dosage and Administration

dental use only

Description

sodium fluoride

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Propolis extract, Turmeric extract, Xylitol, Grapefruit seed extract, Aloe extract, Matricaria extract, Rosemary extract, Green tea extract, Mulberry root extract, L-menthol, Peppermint oil, Polyoxyethylene castor oil, Poloxamer 407, Sodium benzoate, Concentrated glycerin, Steviol glycoside, Flavoring agent, Purified water

Section 51945-4

Section 55105-1

Helps prevent and reduce:

Plaque formation

Dental cavities

Gum bleeding, soreness, and inflammation

Halitosis

Section 55106-9

sodium fluoride


Structured Label Content

Indications and Usage (34067-9)

- Adults and children 6 years of age and older:

Rinse for 60 secondswith 10ml (2 teaspoonful) and then spit out

Do not swallow the rinse

Supervise children as necessary until capable of using without supervision

- Children under 6

Consult a dentist or physician

Dosage and Administration (34068-7)

dental use only

Warnings and Precautions (34071-1)

Keep out of reach of children under 6 years of age.

Do not swallow

If accidentally swallowed, get medical help or contact Poison Control Center right away.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Propolis extract, Turmeric extract, Xylitol, Grapefruit seed extract, Aloe extract, Matricaria extract, Rosemary extract, Green tea extract, Mulberry root extract, L-menthol, Peppermint oil, Polyoxyethylene castor oil, Poloxamer 407, Sodium benzoate, Concentrated glycerin, Steviol glycoside, Flavoring agent, Purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps prevent and reduce:

Plaque formation

Dental cavities

Gum bleeding, soreness, and inflammation

Halitosis

Section 55106-9 (55106-9)

sodium fluoride


Advanced Ingredient Data


Raw Label Data

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