Family Wellness Kids Anticavity

Manufacturer
Family Dollar Services, Inc
Effective date
2020-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:45:24

Label at a glance#

ProductFamily Wellness Kids Anticavity
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Storage and handling

Other information Store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
Sodium fluoride 0.05% (Fluoride ion-0.0226%)

OTC - PURPOSE SECTION

Purpose

Anticavity rinse

INDICATIONS & USAGE SECTION

Use aids in the prevention of dental cavities.

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 6 years of age and older, use once a day after brushing your teeth with toothpaste
  • remove cap
  • use approximately one tablespoon and rinse vigorouslybetween 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
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients
Benzyl Alcohol, Calcium Disodium EDTA, Cetylpyridinium Chloride, Disodium Phosphate, Flavor, Poloxamer 407, Polysorbate 80, Propylene Glycol, Red 33, Sodium Benzoate, Sodium Phosphate, Sodium Saccharin, Sorbitol, Water.

STORAGE AND HANDLING SECTION

Other information

  • Store at room temperature

SPL UNCLASSIFIED SECTION

* Anticavity Fluoride Rinse is not manufactured or distributed by Personal Care Products Company divsion of McNeil-PPC, distributor of Act®.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Midwood Brands, LLC.

500 Volvo Parkway, Chesapeake, VA 23320

MADE IN CANADA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ACT® ACTIVE INGREDIENT*

FAMILY wellness™

KIDS ANTICAVITY FLUORIDE RINSE

BUBBLEGUM

  • Helps Prevent Cavities
  • Helps Kill Germs that Cause Bad Breath
  • Freshens Breath

ALCOHOL FREE

18 FL. OZ. (532ml)

FW Kids Anticavity Rinse-BbgFW Kids Anticavity Rinse-Bbg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-214-442021-11-30C16284748780-1c7ccaba7-1d76-fd44-e053-dadaa90aa01bFamily Wellness Kids Anticavity Fluoride Rinse
55319-214-442021-07-23C16284748780-1c7ccaba7-1d76-fd44-e053-dadaa90aa01bFamily Wellness Kids Anticavity Fluoride Rinse

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-21455319-214-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

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
d204d3f4-dd6e-4ca8-e053-2995a90ae34a9c3400ab-12bc-d67b-e053-2a95a90a11692021-11-30WarningsExact identifier
spl set id: 9c3400ab-12bc-d67b-e053-2a95a90a1169

Reported adverse events (FAERS/openFDA)#

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