SPL v3
SPL
SPL Set ID 23807810-990a-b723-e063-6394a90aee3e
Route
DENTAL
Published
Effective Date 2024-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.02 g)
Inactive Ingredients
Water Glycerin Sodium Phosphate, Monobasic, Anhydrous Potassium Citrate Xylitol Poloxamer 407 Phosphoric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-07-01 Until 2027-11-30

Description

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Use

aids in the prevention of dental cavities.

Directions

Adults and children 6 years of age and older:

Use once a day after brushing your teeth with a toothpaste.

Vigorously swith 10 mL (2 teaspoons) of rinse between your teeth for 1 minute and then spit out.

Do not swallow the rinse.

Do not eat or drink for 30 minutes after rinsing.

Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).

Surpervise children as necessary until capable of using without supervision.

Children under 6 years of age: consult dentist or doctor.

Questions?

1-855-444-3556

Dist. by Hello Products LLC

Montclair, NJ 07042

Active Ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Other Information

Store at room temperature

Do not use if printed band around cap is broken or missing.

Inactive Ingredients

purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, potassium citrate, phosphoric acid.

Keep Out of Reach of Children.

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

Principal Display Panel 520 Ml Bottle Label

hello

unicorn splash

anticavity fluoride rinse

bubble gum

natural flavor

prevents cavities • no alcohol

strengthens teeth

17.6 FL OZ (1.1 PT) 520 mL

PS0086273

IMPORTANT:

Read directions for proper use.


Structured Label Content

Use

aids in the prevention of dental cavities.

Purpose

Anticavity

Directions

Adults and children 6 years of age and older:

Use once a day after brushing your teeth with a toothpaste.

Vigorously swith 10 mL (2 teaspoons) of rinse between your teeth for 1 minute and then spit out.

Do not swallow the rinse.

Do not eat or drink for 30 minutes after rinsing.

Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).

Surpervise children as necessary until capable of using without supervision.

Children under 6 years of age: consult dentist or doctor.

Questions?

1-855-444-3556

Dist. by Hello Products LLC

Montclair, NJ 07042

Active Ingredient (Active ingredient)

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Other Information (Other information)

Store at room temperature

Do not use if printed band around cap is broken or missing.

Inactive Ingredients (Inactive ingredients)

purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, potassium citrate, phosphoric acid.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Principal Display Panel 520 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 520 mL Bottle Label)

hello

unicorn splash

anticavity fluoride rinse

bubble gum

natural flavor

prevents cavities • no alcohol

strengthens teeth

17.6 FL OZ (1.1 PT) 520 mL

PS0086273

IMPORTANT:

Read directions for proper use.


Advanced Ingredient Data


Raw Label Data

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