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Anticavity

Basics 435.000/435AA Anticavity Whitening Rinse

Approved
Approval ID

4a0220f8-748f-4a4a-9a8b-948756468f82

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

Amazon.com Services LLC

DUNS: 128990418

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium fluoride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72288-439
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sodium fluoride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (10)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HYDROGEN PEROXIDEInactive
Code: BBX060AN9V
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NN
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 0.2 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/15/2025

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

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/15/2025

Use

Aids in the prevention of dental cavities

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 9/15/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/15/2025

Active Ingredient

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/15/2025

Purpose

Anticavity

WARNINGS SECTION

LOINC: 34071-1Updated: 9/15/2025

Warnings

for this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/15/2025

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/15/2025

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/15/2025

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/15/2025

Claims

Contains peroxide which releases oxygen while whitening.

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

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Anticavity - FDA Drug Approval Details