WILLO BERRY SPLASH DYE FREE- sodium fluoride paste, dentifrice

Willo Berry Splash Dye Free by

Drug Labeling and Warnings

Willo Berry Splash Dye Free by is a Otc medication manufactured, distributed, or labeled by Willo 32, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Application instructions

Apply 2 to 3 pumps of foaming toothpaste evenly along the brush head.

Drug Facts

Active ingredient

Sodium fluoride 0.22%

(0.10% w/v fluoride ion)

Purpose

Purpose

Anticavity

Use

Use Aids in the prevention of dental cavities.

Warnings Section

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

Warnings

Warnings

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 Poison Control Center right away.

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 and rinsing habits (to minimize swallowing. Supervise as necessary until capable of using without supervision
• children under 2 years of age: consult a dentist or doctor.

Inactive ingredients list

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

Questions section

Questions or comments?

Tel: 1(888)509-0459 - Email: support@willo.com

Visit us at www.willo.com

Flavor description

STRAWBERRY FLAVOR

Information panel

Helps Prevent Cavities & Strengthens Enamel

Dye free

SLS free

Sulfate free

Paraben free

Gluten free

♲

Dist. by: Willo 32, Inc

New York, NY 10006

1 (888) 509-0459

Box Image

8 oz Label image

PRINCIPAL DISPLAY PANEL

Willo

Berry Splash

Anticavity Fluoride

Foaming Toothpaste

Two 2 fl oz (59 ml) bottles

INGREDIENTS AND APPEARANCE

WILLO BERRY SPLASH DYE FREE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84185-202
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM CITRATE (UNII: MLM29U2X85)
SORBITOL (UNII: 506T60A25R)
PEG-400 (UNII: 2AS3MDK9CB)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
MENTHOL (UNII: L7T10EIP3A)
STEVIOSIDE (UNII: 0YON5MXJ9P)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
CITRIC ACID (UNII: 2968PHW8QP)
YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84185-202-22	2 in 1 BOX	09/11/2025
1	NDC: 84185-202-02	59 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 84185-202-08	237 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/11/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	09/10/2025

Labeler - Willo 32, Inc (105977106)