Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ca19f21b-2b03-52b5-e053-2a95a90a0780
Route
DENTAL
Published
Effective Date 2021-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.74 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-08-22

Description

sodium fluoride


Medication Information

Warnings and Precautions

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

- Adults and children 2 years or older:

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

- Children 2 to 6 years

Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).

- Children under 2 years of age:

Ask 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

Hydroxyapatite, Curcuma extract, Xylitol, Centella asiatica extract, Houttuynia cordata extract, Green tea extract, Salvia officinalis extract, Eucalyptus globulus extract. Flavoring agent, Sodium cocoyl isethionate, Sodium cocoyl glutamate, Carboxymethylcellulose sodium, D-sorbitol solution, Enzymatically modified stevia, Purified water

Section 51945-4

Section 55105-1

Helps protect against cavities

Section 55106-9

sodium fluoride


Structured Label Content

Indications and Usage (34067-9)

- Adults and children 2 years or older:

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

- Children 2 to 6 years

Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).

- Children under 2 years of age:

Ask 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.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Hydroxyapatite, Curcuma extract, Xylitol, Centella asiatica extract, Houttuynia cordata extract, Green tea extract, Salvia officinalis extract, Eucalyptus globulus extract. Flavoring agent, Sodium cocoyl isethionate, Sodium cocoyl glutamate, Carboxymethylcellulose sodium, D-sorbitol solution, Enzymatically modified stevia, Purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps protect against cavities

Section 55106-9 (55106-9)

sodium fluoride


Advanced Ingredient Data


Raw Label Data

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