Basics 004.002/004ae

Basics 004.002/004ae
SPL v22
SPL
SPL Set ID 90d57288-711e-4d5e-8c9d-db7a4456a256
Route
ORAL
Published
Effective Date 2025-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Benzyl Alcohol Edetate Calcium Disodium Anhydrous Cetylpyridinium Chloride Edetate Disodium Sodium Phosphate, Dibasic, Anhydrous Poloxamer 407 Polysorbate 80 Propylene Glycol D&c Red No. 33 Sodium Benzoate Sodium Phosphate Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-04-25 Until 2026-01-11

Description

Quality products for your everyday moments.

Purpose

Anticavity 

Adverse Reactions

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


Medication Information

Purpose

Anticavity 

Adverse Reactions

DISTRIBUTED BY:

Amazon.com Services, LLC

Seattle, WA 98109  1-877-485-0385

©2025 Amazon Basics Services LLC, or its affilates. All rights reserved. 

www.amazon.com/amazonbasics

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Description

Quality products for your everyday moments.

Use

aids in the prevention of dental cavities

Claim

Quality products for your everyday moments.

Warnings

for this product

Directions

Adults and children 6 year 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 year of age: consult a dentist or doctor

Active Ingredient

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

Other Information
  • store at room temperature
Inactive Ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel

amazon basics

Bubble Gum

Kids Anticavity Fluoride Rinse

Alcohol Free

Bubble Gum

IMPORTANT: READ DIRECTIONS FOR PROPER USE

18 FL OZ (1.12 PT) 532 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, seek professional assistance or contact a Poison Control Center immediately.


Structured Label Content

Use

aids in the prevention of dental cavities

Claim

Quality products for your everyday moments.

Purpose

Anticavity 

Warnings

for this product

Directions

Adults and children 6 year 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 year of age: consult a dentist or doctor

Active Ingredient (Active ingredient)

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

Adverse Reactions (Adverse reactions)

DISTRIBUTED BY:

Amazon.com Services, LLC

Seattle, WA 98109  1-877-485-0385

©2025 Amazon Basics Services LLC, or its affilates. All rights reserved. 

www.amazon.com/amazonbasics

Discard Seal, Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel (principal display panel)

amazon basics

Bubble Gum

Kids Anticavity Fluoride Rinse

Alcohol Free

Bubble Gum

IMPORTANT: READ DIRECTIONS FOR PROPER USE

18 FL OZ (1.12 PT) 532 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, seek professional assistance or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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