Care One 163.005/163AF-AG

Manufacturer
ADUSA Distribution, LLC | Nice-Pak Products, LLC
Effective date
2026-04-07
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:52:54

Label at a glance#

ProductAnticavity
Active ingredientSODIUM FLUORIDE
Label structure12 sections

Dosage and administration

Adults and children 12 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 of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using ...

Storage and handling

store at controlled room temperature 20⁰ - 25⁰ C(68⁰ - 77⁰ F) cold weather may temporarily cloud this product

Label contents#

Full prescribing information#

Tamper Evident Statement

SPL UNCLASSIFIED SECTION

Sealed With Printed Neckband For Your Protection

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% w/v (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 12 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 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 controlled room temperature 20⁰ - 25⁰ C(68⁰ - 77⁰ F)
  • cold weather may temporarily cloud this product

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ® Total Care Fresh Mint Anticavity Mouthwash.

ADVERSE REACTION

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

CARE ONE ®

Compare to Listerine ® Total Care Fresh Mint Anticavity Mouthwash*

ANTICAVITY

MOUTHWASH

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

Helps prevent cavities and restore enamel

Helps strengthen teeth 

Freshens breath

Mint Flavor

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1.05 QT) 1 L

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 RinsePSN14
313029sodium fluoride 0.2 MG/ML MouthwashSCD14
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY14
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY14

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0002307BHmm02.jpg
Data codeData MatrixL0002307FGmm01.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
72476-005-86Anticavity1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100014

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-00572476-005-86

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
132026-02-06monthly-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, LLC35385ada-bd8d-4d38-9587-0256885f749f2026-04-07Warnings, Adverse reactionsExact identifier
ndc (package): 72476-005-86
ndc (product): 72476-005
ndc11 (package): 72476000586
spl id: 4ee13c2d-367d-8edf-e063-6394a90a963b
spl set id: 35385ada-bd8d-4d38-9587-0256885f749f

Reported adverse events (FAERS/openFDA)#

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