Basics 482.002/482ac

Basics 482.002/482ac
SPL v12
SPL
SPL Set ID 349eca80-2e0c-409b-af29-3235fdc0695b
Route
ORAL
Published
Effective Date 2026-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Glycerin Water Cetylpyridinium Chloride Cinnamaldehyde Saccharin Sodium Phosphoric Acid Sodium Benzoate Sucralose Poloxamer 407 Benzoic Acid Sodium Phosphate, Dibasic, Anhydrous Propylene Glycol D&c Red No. 33 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-01

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

Purpose

Anticavity

Adverse Reactions

Made in USA with US and foreign components. DISTRIBUTED BY: Amazon.com Services LLC Seattle, WA 98109 1-877-485-0385 © 2025 Amazon.com, Inc. or its affiliates. All rights reserved. www.amazon.com/amazonbasics PLASTIC BOTTLE Widely Recyclable Discard Seal, Empty & Replace Cap how2recycle.info


Medication Information

Purpose

Anticavity

Adverse Reactions

Made in USA with US and foreign components.

DISTRIBUTED BY: Amazon.com Services LLC

Seattle, WA 98109 1-877-485-0385

© 2025 Amazon.com, Inc. or its affiliates.

All rights reserved.

www.amazon.com/amazonbasics

PLASTIC BOTTLE

Widely Recyclable

Discard Seal, Empty & Replace Cap

how2recycle.info

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

Use

aids in the prevention of dental cavities

Claims

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

Warnings

for this product

Directions

Adults and children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) 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 Procter & Gamble, distributor of Crest ®Pro-Health Advanced Anticavity Fluoride Mouthwash.

Active Ingredient

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

Inactive Ingredients

water, glycerin, cetylpyridinium chloride, flavor, cinnamal, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Principal Display Panel

amazon basics

Violet Mint

Anticavity Fluoride Mouthwash

Alcohol Free

Violet Mint Flavor

Compare to Crest ®Pro-Health ®Advanced Anticavity Fluoride Mouthwash*

IMPORTANT: RED DIRECTIONS FOR PROPER USE

1 L (1.05 QT) 33.8 FL OZ

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

This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

Purpose

Anticavity

Warnings

for this product

Directions

Adults and children 6 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) 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 Procter & Gamble, distributor of Crest ®Pro-Health Advanced Anticavity Fluoride Mouthwash.

Active Ingredient (Active ingredient)

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

Adverse Reactions

Made in USA with US and foreign components.

DISTRIBUTED BY: Amazon.com Services LLC

Seattle, WA 98109 1-877-485-0385

© 2025 Amazon.com, Inc. or its affiliates.

All rights reserved.

www.amazon.com/amazonbasics

PLASTIC BOTTLE

Widely Recyclable

Discard Seal, Empty & Replace Cap

how2recycle.info

Inactive Ingredients (Inactive ingredients)

water, glycerin, cetylpyridinium chloride, flavor, cinnamal, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Principal Display Panel (principal display panel)

amazon basics

Violet Mint

Anticavity Fluoride Mouthwash

Alcohol Free

Violet Mint Flavor

Compare to Crest ®Pro-Health ®Advanced Anticavity Fluoride Mouthwash*

IMPORTANT: RED DIRECTIONS FOR PROPER USE

1 L (1.05 QT) 33.8 FL OZ

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


Raw Label Data

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