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Theory

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-08-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:09:32

Label at a glance#

ProductTheory Freshness Care Essential Mint
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children's brushing until good habits are established children under 2 yrs.: ask a dentist

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - WHEN USING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

sorbitol, water, hydrated silica, cocamidopropyl betaine, cellulose gum, flavor*, stevia rebaudiana extract, trisodium phosphate, sodium phosphate, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-866-961-2375

PRINCIPAL DISPLAY PANEL - 104 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NET WT 3.7 OZ (104 g)

theory.

fluoride anticavity toothpaste

FRESHNESS CARE

ESSENTIAL MINT

Designed with science in mind.
Made with fluoride to remineralize
enamel, prevent cavities, and nourish
teeth. No extraneous ingredients.
Made without dyes, parabens, and SLS.
No added artificial flavors -
only real mint.

6942391969423919

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
69423-91969423-919-37

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM PHOSPHATESE337SVY37IACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
STEVIA REBAUDIANA WHOLE6U422Y08O2IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
40aac35c-9026-0133-e063-6294a90a3fe8c47db741-2a92-d8f2-e053-2995a90aca412025-10-08WarningsExact identifier
spl set id: c47db741-2a92-d8f2-e053-2995a90aca41

Reported adverse events (FAERS/openFDA)#

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