Childrens Anticavity Fluoride Rinse

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.05 mg)

Inactive Ingredients

Water Sorbitol Propylene Glycol Poloxamer 407 Benzyl Alcohol Disodium Phosphate Sodium Benzoate Sodium Saccharin Polysorbate 80 Cetylpyridinium Chloride Calcium Disodium Edta D&c Red No. 33 Sodium Phosphate, Monobasic, Unspecified Form

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-10-01

Medication Information

Purpose

Anticavity rinse

Description

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

Uses

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 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

Package Label

FAMILY WELLNESS Children's Anticavity Fluoride Rinse Bubble Gum

Active Ingredient

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

Other Information

■ store at room temperature

■ do not use if safety seal is broken or missing

Inactive Ingredients

water, sorbitol, propylene glycol, flavor, poloxamer 407, monosodium phosphate, benzyl alcohol, disodium phosphate, sodium benzoate, sodium saccharin, polysorbate 80, cetylpyridinium chloride, calcium disodium EDTA, D&C red no. 33

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse*

Children's

ANTICAVITY

FLUORIDE RINSE

6+ YEARS

Sodium Fluoride 0.05%

Help prevent cavities
Alcohol Free

IMPORTANT: Read directions for proper use.

BUBBLEGUM FLAVOR

TAMPER EVIDENT: DO NOT USE IF PRINTER SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Chattem Inc., distributor of ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

510 VOLVO PKWY, CHESAPEAKE, VA 23320

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Structured Label Content

Uses

aids in the prevention of dental cavities

Purpose

Anticavity rinse

Directions

Adults and children 6 years of age and older:

■ use once a day after brushing your teeth with a toothpaste

■ 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

Package Label (Package label)

FAMILY WELLNESS Children's Anticavity Fluoride Rinse Bubble Gum

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 safety seal is broken or missing

Inactive Ingredients (Inactive ingredients)

water, sorbitol, propylene glycol, flavor, poloxamer 407, monosodium phosphate, benzyl alcohol, disodium phosphate, sodium benzoate, sodium saccharin, polysorbate 80, cetylpyridinium chloride, calcium disodium EDTA, D&C red no. 33

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel (Principal display panel)

Compare to the active ingredient in ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse*

Children's

ANTICAVITY

FLUORIDE RINSE

6+ YEARS

Sodium Fluoride 0.05%

Help prevent cavities
Alcohol Free

IMPORTANT: Read directions for proper use.

BUBBLEGUM FLAVOR

TAMPER EVIDENT: DO NOT USE IF PRINTER SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Chattem Inc., distributor of ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

510 VOLVO PKWY, CHESAPEAKE, VA 23320

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 (1-800-222-1222) right away.

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DISODIUM PHOSPHATE", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM SACCHARIN", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYLPYRIDINIUM CHLORIDE", "unii": "D9OM4SK49P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM DISODIUM EDTA", "unii": "8U5D034955", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM", "unii": "3980JIH2SW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "aids in the prevention of dental cavities", "Purpose": "Anticavity rinse", "Directions": "Adults and children 6 years of age and older: ■ use once a day after brushing your teeth with a toothpaste ■ 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", "Package label": "FAMILY WELLNESS Children's Anticavity Fluoride Rinse Bubble Gum", "Active ingredient": "Sodium fluoride 0.05% (0.02% w/v fluoride ion)", "Other information": "■ store at room temperature ■ do not use if safety seal is broken or missing", "Inactive ingredients": "water, sorbitol, propylene glycol, flavor, poloxamer 407, monosodium phosphate, benzyl alcohol, disodium phosphate, sodium benzoate, sodium saccharin, polysorbate 80, cetylpyridinium chloride, calcium disodium EDTA, D&C red no. 33", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal display panel": "Compare to the active ingredient in ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse* Children's ANTICAVITY FLUORIDE RINSE 6+ YEARS Sodium Fluoride 0.05% Help prevent cavities Alcohol Free IMPORTANT: Read directions for proper use. BUBBLEGUM FLAVOR TAMPER EVIDENT: DO NOT USE IF PRINTER SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. *This product is not manufactured or distributed by Chattem Inc., distributor of ACT® Bubblegum Blowout® Anticavity Kids Fluoride Rinse DISTRIBUTED BY: MIDWOOD BRANDS, LLC 510 VOLVO PKWY, CHESAPEAKE, VA 23320", "Keep out of reach of children.": "If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."}

Childrens Anticavity Fluoride Rinse

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information