Meijer 838.000/838ab

SPL v3

SPL

SPL Set ID 0bb9fb5f-1893-4187-b60b-05319a8fac6a

Route

ORAL

Published

Effective Date 2025-10-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.2 mg)

Inactive Ingredients

Glycerin Sodium Benzoate Water Potassium Sorbate Xylitol Citric Acid Monohydrate Sucralose Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-09-29

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Purpose

Anticavity

Adverse Reactions

OUR QUALITY GUARANTEE The Meijer Family www.meijer.com/satisfaction Questions 1-888-593-0593 DISTRIBUTED BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com

Medication Information

Purpose

Anticavity

Adverse Reactions

OUR QUALITY GUARANTEE

The Meijer Family

www.meijer.com/satisfaction

Questions 1-888-593-0593

DISTRIBUTED BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Use

aids in the prevention of dental cavities

Warnings

For this product

Directions

adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
remove cap
pour 10 milliliters (10 ML mark on inside of cap); do not fill above 10 ML mark
vigorously swish 10 milliliters 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)
supervise children as necessary until capable of using without supervision
children under 6 years of age: consult a dentist or doctor

Disclaimer

*This product is not manufactured or distributed by Church & Dwight Co. Inc., distributor of TheraBreath ^®for Kids! Anticavity Fluoride Oral Rinse Wacky Watermelon.

Active Ingredient

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

Other Information

store at room temperature

Inactive Ingredients

water, glycerin, sodium benzoate, potassium sorbate, flavor, xylitol, citric acid, sucralose, sodium citrate

Principal Display Panel

NDC 79481-0838-1

meijer ^®

COMPARE TO THERABREATH ^® FOR KIDS! WACKY WATERMELON*

Kids

Anticavity Fluoride

Oral Rinse

Wonderful Watermelon

Strong Cavity Protection

Dye, Alcohol & Sugar Free

Helps Strengthen Teeth

IMPORTANT: read directions for proper use.

10 FL OZ (296 mL)

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity

Warnings

For this product

Directions

adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
remove cap
pour 10 milliliters (10 ML mark on inside of cap); do not fill above 10 ML mark
vigorously swish 10 milliliters 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)
supervise children as necessary until capable of using without supervision
children under 6 years of age: consult a dentist or doctor

Disclaimer

*This product is not manufactured or distributed by Church & Dwight Co. Inc., distributor of TheraBreath ^®for Kids! Anticavity Fluoride Oral Rinse Wacky Watermelon.

Adverse Reactions (ADVERSE REACTIONS)

OUR QUALITY GUARANTEE

The Meijer Family

www.meijer.com/satisfaction

Questions 1-888-593-0593

DISTRIBUTED BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

Active Ingredient (Active ingredient)

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

Other Information (Other information)

store at room temperature

Inactive Ingredients (Inactive ingredients)

water, glycerin, sodium benzoate, potassium sorbate, flavor, xylitol, citric acid, sucralose, sodium citrate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 79481-0838-1

meijer ^®

COMPARE TO THERABREATH ^® FOR KIDS! WACKY WATERMELON*

Kids

Anticavity Fluoride

Oral Rinse

Wonderful Watermelon

Strong Cavity Protection

Dye, Alcohol & Sugar Free

Helps Strengthen Teeth

IMPORTANT: read directions for proper use.

10 FL OZ (296 mL)

Tamper Evident Statement (TAMPER EVIDENT STATEMENT)

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "Purpose": "Anticavity", "Warnings": "For this product", "Directions": "adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters (10 ML mark on inside of cap); do not fill above 10 ML mark vigorously swish 10 milliliters 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) supervise children as necessary until capable of using without supervision children under 6 years of age: consult a dentist or doctor", "Disclaimer": "*This product is not manufactured or distributed by Church & Dwight Co. Inc., distributor of TheraBreath ® for Kids! Anticavity Fluoride Oral Rinse Wacky Watermelon. ", "ADVERSE REACTIONS": "OUR QUALITY GUARANTEE The Meijer Family www.meijer.com/satisfaction Questions 1-888-593-0593 DISTRIBUTED BY MEIJER DISTRIBUTION, INC. GRAND RAPIDS, MI 49544 www.meijer.com", "Active ingredient": "Sodium fluoride 0.05% (0.02% w/v fluoride ion)", "Other information": "store at room temperature", "Inactive ingredients": "water, glycerin, sodium benzoate, potassium sorbate, flavor, xylitol, citric acid, sucralose, sodium citrate", "PRINCIPAL DISPLAY PANEL": "NDC 79481-0838-1 meijer ® COMPARE TO THERABREATH ® FOR KIDS! WACKY WATERMELON* Kids Anticavity Fluoride Oral Rinse Wonderful Watermelon Strong Cavity Protection Dye, Alcohol & Sugar Free Helps Strengthen Teeth IMPORTANT: read directions for proper use. 10 FL OZ (296 mL)", "TAMPER EVIDENT STATEMENT": "SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION", "Keep out of reach of children.": "If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:06.709920 · Updated: 2026-03-14T23:13:48.939099