3ee5b49e-ca9a-ece6-e063-6394a90a3d00

SPL v1
SPL
SPL Set ID 3ee5b49e-ca9a-ece6-e063-6394a90a3d00
Route
dental
Published
Effective Date 2025-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1 mg)
Inactive Ingredients
sorbitol sodium benzoate calcium citrate sodium bicarbonate yeast .beta.-d-glucan peg-400 sodium cocoyl glutamate stevioside menthol sodium ascorbyl phosphate water glycerin sucralose citric acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-09-16

Purpose

Purpose Anticavity

Description

Active ingredient Sodium fluoride 0.22% (0.10% w/v fluoride ion)


Medication Information

Warnings

Warnings

Purpose

Purpose

Anticavity

Directions

Directions

adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor
children under 6 years of age instruct in good brushing habits (to minimize swallowing). Supervise as necessary until capable or using without supervision
children under 2 years of age consult with a dentist or doctor

Inactive Ingredients

Inactive ingredients Water, Sorbitol, Sodium Cocoyl Glutamate, Glycerin, PEG-400, Sucralose, Flavor, Citric Acid, Beta-Glucan, Sodium Bicarbonate, Sodium Benzoate, Sodium Ascorbyl Phosphate, Stevioside, Menthol, Calcium Citrate

Description

Active ingredient Sodium fluoride 0.22% (0.10% w/v fluoride ion)

Use

Use Aids in the prevention of dental cavities

Section 51945-4

Willo

Minty Mist

Anticavity Fluoride

Liquid Toothpaste

Helps Prevent Cavities

& Strengthens Enamel

8 fl oz (237 ml)

Scan code to buy another bottle

Dist. by: Willo 32, Ince

New York, NY 10006

1 (888) 509-0459

Drug Facts

Active ingredient

Sodium fluoride 0.22%

(0.10% w/v fluoride ion)

Free of Claims

Dye free

SLS free

Sulfate free

Paraben free

Gluten free

Flavor Description

MINT FLAVOR

Broken Seal Warning

Do not use if seal under cap is broken or missing

Questions Or Comments

Questions or comments?

Tel: 1(888)509-0459 - Email: [email protected]

Visit us at www.willo.com

Keep Out of Reach of Children

Keep out of reach of children under 6 years of age, without adult supervision. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

Warnings

Purpose

Purpose

Anticavity

Directions

Directions

adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor
children under 6 years of age instruct in good brushing habits (to minimize swallowing). Supervise as necessary until capable or using without supervision
children under 2 years of age consult with a dentist or doctor

Inactive Ingredients (Inactive ingredients)

Inactive ingredients Water, Sorbitol, Sodium Cocoyl Glutamate, Glycerin, PEG-400, Sucralose, Flavor, Citric Acid, Beta-Glucan, Sodium Bicarbonate, Sodium Benzoate, Sodium Ascorbyl Phosphate, Stevioside, Menthol, Calcium Citrate

Use

Use Aids in the prevention of dental cavities

Section 51945-4 (51945-4)

Willo

Minty Mist

Anticavity Fluoride

Liquid Toothpaste

Helps Prevent Cavities

& Strengthens Enamel

8 fl oz (237 ml)

Scan code to buy another bottle

Dist. by: Willo 32, Ince

New York, NY 10006

1 (888) 509-0459

Drug Facts

Active ingredient

Sodium fluoride 0.22%

(0.10% w/v fluoride ion)

Free of Claims (Free of claims)

Dye free

SLS free

Sulfate free

Paraben free

Gluten free

Flavor Description (Flavor description)

MINT FLAVOR

Broken Seal Warning (Broken seal warning)

Do not use if seal under cap is broken or missing

Questions Or Comments (Questions or comments)

Questions or comments?

Tel: 1(888)509-0459 - Email: [email protected]

Visit us at www.willo.com

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

Keep out of reach of children under 6 years of age, without adult supervision. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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