85215-002

85215-002
SPL v1
SPL
SPL Set ID 3573f149-2af9-4c86-e063-6294a90a7b3f
Route
DENTAL
Published
Effective Date 2025-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.25 g)
Inactive Ingredients
Xanthan Gum Sodium Benzoate Glycerin Xylitol Sodium Saccharin Sodium Lauroyl Sarcosinate Sodium Pyrophosphate Menthol Sorbitol Aqua Silica Hydrogen Peroxide Carboxymethylcellulose Schisandra Chinensis Fruit Asian Ginseng

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-19

Description

Sodium fluoride 0.25% (100PPM)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.25% (100PPM)

Use

Use helps protect against cavities

Section 50565-1

Keep out of Teach 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 50566-9

When using this product keep out of eyes

Section 50567-7

When using this product

Do not swallow

Warnings

When using this product

Do not swallow

Do not use in eye area

Directions

Directions ■Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after

each meal or at east twice a day, or use as directed by a dentist or doctor.

■Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

■Supervise children as necessary until capable of using without supervision.

■Children under 2 years of age: Consult a dentist or doctor.

Do Not Use

Do not use in eye area

Other Information

Store in a cool and shady place

Active Ingredient(s)

Sodium fluoride 0.25% (100PPM)

Inactive Ingredients

Sorbitol, Aqua, Hydrated Silica, Glycerin, Sodium Lauroy| Sarcosinate, Fragrancel Flavor, Nano-Hydroxyapatite, Xanthan

Gum, Menthol, Sodium Benzoate, CarboxymethyI Cellulose, Sodium Saccharin, Xylitol, Sodium Pyrophosphate, Red Dates Extract, Ginseng Extract, Hydrogen Peroxide (PVP-H202).

Package Label Principal Display Panel


Structured Label Content

Use

Use helps protect against cavities

Section 50565-1 (50565-1)

Keep out of Teach 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 50566-9 (50566-9)

When using this product keep out of eyes

Section 50567-7 (50567-7)

When using this product

Do not swallow

Purpose

Anticavity

Warnings

When using this product

Do not swallow

Do not use in eye area

Directions

Directions ■Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after

each meal or at east twice a day, or use as directed by a dentist or doctor.

■Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

■Supervise children as necessary until capable of using without supervision.

■Children under 2 years of age: Consult a dentist or doctor.

Do Not Use (Do not use)

Do not use in eye area

Other Information (Other information)

Store in a cool and shady place

Active Ingredient(s)

Sodium fluoride 0.25% (100PPM)

Inactive Ingredients (Inactive ingredients)

Sorbitol, Aqua, Hydrated Silica, Glycerin, Sodium Lauroy| Sarcosinate, Fragrancel Flavor, Nano-Hydroxyapatite, Xanthan

Gum, Menthol, Sodium Benzoate, CarboxymethyI Cellulose, Sodium Saccharin, Xylitol, Sodium Pyrophosphate, Red Dates Extract, Ginseng Extract, Hydrogen Peroxide (PVP-H202).

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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