Basics 435.000/435aa

SPL v15

SPL

SPL Set ID 4a0220f8-748f-4a4a-9a8b-948756468f82

Route

ORAL

Published

Effective Date 2025-09-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.2 mg)

Inactive Ingredients

Water Alcohol Hydrogen Peroxide Poloxamer 407 Saccharin Sodium Sucralose Menthol Phosphoric Acid Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2018-05-01 Until 2018-06-01

Description

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Adverse Reactions

DISTRIBUTED BY: Amazon.com Services, LLC Seattle, WA 98109 1-877-485-0385 © 2025 Amazon Basics Services LLC, or its affiliates. All rights reserved. www.amazon.com/amazonbasics Discard Seal, Empty & Replace Cap PLASTIC BOTTLE how2recycle.info DSP-TN-21091 DSP-MO-20087

Medication Information

Purpose

Anticavity

Adverse Reactions

DISTRIBUTED BY:

Amazon.com Services, LLC

Seattle, WA 98109 1-877-485-0385

www.amazon.com/amazonbasics

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

DSP-TN-21091 DSP-MO-20087

Description

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Use

Aids in the prevention of dental cavities

Claims

Contains peroxide which releases oxygen while whitening.

This may cause the bottle to inflate slightly or release air when opened.

Warnings

for this product

Directions

Adults and children 6 years of age and older:

use twice 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

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Other Information

store at room temperature (59º-77ºF)

Inactive Ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Principal Display Panel

amazon basics

Fresh Mint

Whitening

Anticavity

Mouthwash

Removes surface stains from teeth

Fresh Mint

IMPORTANT: READ DIRECTIONS FOR PROPER USE

16 FL OZ (1 PT) 473 mL

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

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.

Structured Label Content

Use

Aids in the prevention of dental cavities

Claims

Contains peroxide which releases oxygen while whitening.

This may cause the bottle to inflate slightly or release air when opened.

Purpose

Anticavity

Warnings

for this product

Directions

Adults and children 6 years of age and older:

use twice 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

Adverse Reactions (ADVERSE REACTIONS)

DISTRIBUTED BY:

Amazon.com Services, LLC

Seattle, WA 98109 1-877-485-0385

www.amazon.com/amazonbasics

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

DSP-TN-21091 DSP-MO-20087

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Other Information (Other information)

store at room temperature (59º-77ºF)

Inactive Ingredients (Inactive ingredients)

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Principal Display Panel (principal display panel)

amazon basics

Fresh Mint

Whitening

Anticavity

Mouthwash

Removes surface stains from teeth

Fresh Mint

IMPORTANT: READ DIRECTIONS FOR PROPER USE

16 FL OZ (1 PT) 473 mL

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

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.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORIC ACID", "unii": "E4GA8884NN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "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", "Claims": "Contains peroxide which releases oxygen while whitening. This may cause the bottle to inflate slightly or release air when opened.", "Purpose": "Anticavity", "Warnings": "for this product", "Directions": "Adults and children 6 years of age and older: use twice 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", "ADVERSE REACTIONS": "DISTRIBUTED BY: Amazon.com Services, LLC Seattle, WA 98109 1-877-485-0385 © 2025 Amazon Basics Services LLC, or its affiliates. All rights reserved. www.amazon.com/amazonbasics Discard Seal, Empty & Replace Cap PLASTIC BOTTLE how2recycle.info DSP-TN-21091 DSP-MO-20087", "Active Ingredient": "Sodium fluoride 0.02% (0.01% w/v fluoride ion)", "Other information": "store at room temperature (59º-77ºF)", "Inactive ingredients": "water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor", "principal display panel": "amazon basics Fresh Mint Whitening Anticavity Mouthwash Removes surface stains from teeth Fresh Mint IMPORTANT: READ DIRECTIONS FOR PROPER USE 16 FL OZ (1 PT) 473 mL", "Tamper Evident Statement": "SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:01.209512 · Updated: 2026-03-14T23:14:04.878170