Care One 435.000/435AA

Manufacturer
ADUSA Distribution, LLC | Nice-Pak Products, LLC
Effective date
2026-04-07
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:53:05

Label at a glance#

ProductAnticavity
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

Adults and children 6 years of age and older: use twice a day 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 u...

Storage and handling

store at room temperature (59º-77ºF)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

For this product

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:

  • use twice a day 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

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature (59º-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Disclaimer

SPL UNCLASSIFIED SECTION

Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate slightly or release air when opened.

Adverse Reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147 1-833-992-3872

Quality Guaranteed or your money back.

DSP-TN-21091

DSP-MO-20087

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAREONE ®

ADVANCED

WHITENING

ANTICAVITY MOUTHRINSE

5 DAYS TO WHITER TEETH

BEGINS WORKING ON CONTACT

SAFELY WHITENS TEETH

KILLS GERMS THAT CAUSE BAD BREATH

FRESH MINT FLAVOR

Sealed With Printed Neckband For Your Protection

IMPORTANT: Read directions for proper use.

32 FL OZ (1 QT) 946 mL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN16
313029sodium fluoride 0.2 MG/ML MouthwashSCD16
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY16
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY16

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0015065BCmm02.jpg
Data codeData MatrixL0015065FCmm01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-435-43Anticavity473 mL in 1 BOTTLE, PLASTICMOUTHWASH47316
72476-435-45Anticavity946 mL in 1 BOTTLE, PLASTICMOUTHWASH94616

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-43572476-435-45, 72476-435-43

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
152026-02-06monthly-update2026-06-03 17:56:16

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnticavitySODIUM FLUORIDEADUSA Distribution, LLCcf0c8b48-0d1c-406a-a67d-7d16187d38d82026-04-07Warnings, Adverse reactionsExact identifier
ndc (package): 72476-435-45
ndc (package): 72476-435-43
ndc (product): 72476-435
ndc11 (package): 72476043545
ndc11 (package): 72476043543
spl id: 4ee28734-6642-0853-e063-6394a90a1bd7
spl set id: cf0c8b48-0d1c-406a-a67d-7d16187d38d8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.