FDA.reportPublic FDA data

SparkleFresh

Manufacturer
Medline Industries, LP
Effective date
2022-12-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:44:12

Label at a glance#

ProductSparkleFresh
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Dosage and administration

Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or physician.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76%

Purpose

OTC - PURPOSE SECTION

Anticavity Toothpaste

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If you accidentally swallow more than used for brushing, seek medical help or contact a Poison Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: consult a dentist or physician.

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, treated water, sorbitol, precipitated silica, sodium lauryl sulfate, flavor, sodium carboxymethyl cellulose, sodium silicate, tetrasodium pyrophosphate, sodium saccharin, methylparaben, titanium dioxide, polyethylene glycol 400, propylparaben

Manufacturing Information

SPL UNCLASSIFIED SECTION

Medline is a registered trademark and SparkleFresh is a trademark of Medline Industries Inc. Dignity Health and its logo are trademarks of Dignity Health.

Manufactured for: Medline Industries Inc.

Three Lakes Drive, Northfield, IL 60093 USA

Made in India

www.medline.com

1-800-MEDLINE

REF: DGN1000

RC19NWI

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-08153329-081-93

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
GLYCERINPDC6A3C0OXIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
CALCIUM CARBONATEH0G9379FGKIACT

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
03203a60-6e05-fe55-e063-6294a90a62f5308859a9-a5f6-697b-e054-00144ff88e882023-08-17WarningsExact identifier
spl set id: 308859a9-a5f6-697b-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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