Oral7 Dry Mouth Moisturizing

Manufacturer
Oral7 USA Operations Inc
Effective date
2021-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:31

Label at a glance#

ProductOral7 Dry Mouth Moisturizing
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Dosage and administration

Adults and Children 2 years of age and older Use 2-3 times a day, 7 days a week. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor or dentist. 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 den...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76% w/w (1000ppmF)

Purpose

OTC - PURPOSE SECTION

Anti-cavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If symptoms of dry mouth persist, consult a health care professional.

DO NOT use

OTC - DO NOT USE SECTION

if you are allergic to any of the ingredients.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children 2 years of age and older

  • Use 2-3 times a day, 7 days a week.
  • Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor or dentist.
  • 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 doctor.

Other Information

SPL UNCLASSIFIED SECTION

Store below 77° F ( 25° C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

DICALCIUM PHOSPHATE, HYDROGENATED STARCH HYDROLYSATE, GLYCERIN, AQUA, SILICA, DEXTROSE MONOHYDRATE, HYDRATED SILICA, ISOCETETH-20, XYLITOL, SODIUM MONOFLUOROPHOSPHATE, XANTHAN GUM, MENTHA PIPERITA (PEPPERMINT OIL), SODIUM BENZOATE, LACTOPEROXIDASE, POTASSIUM THIOCYANATE, LACTOFERRIN, LYSOZYME, GLUCOSE OXIDASE, LIMONENE, CALCIUM LACTATE

Questions

OTC - QUESTIONS SECTION

or Comments? Tel.: +1 833-672-5787 weekdays or Email : info@oral7us.com / oral7us.com

Always follow the label

SPL UNCLASSIFIED SECTION

ORAL7

REAL DRY MOUTH RELIEF

TOOTHPASTE

Fluoride & Calcium

2.5 fl oz 75 ml (105g)

SUGAR FREE

Naturally Sweetened with Xylitol

Made in the EU

Oral7 International Pty. Ltd.

Suite 2, 15 Delawney Street

Balcatta, WA 6021 AUSTRALIA

USA & Canada

Oral7 U.S. (Op) Inc.info@oral7us.com

www.oral7us.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

boxbox

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81175-000-022024-01-30C16284748780-11030e365-5feb-111a-e063-dadaa90a10e2Oral7 Dry Mouth Moisturizing Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81175-000-02Oral7 Dry Mouth Moisturizing75 mL in 1 TUBEPASTE, DENTIFRICE751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81175-000ORAL7 DRY MOUTH MOISTURIZING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ORAL7 USA OPERATIONS INC]1Legacy NDC, 1 package rows20210716_c4bd3ffa-9a35-894e-e053-2995a90a2c95.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81175-00081175-000-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
c4bd3ffa-9a36-894e-e053-2995a90a2c95c4bd3ffa-9a35-894e-e053-2995a90a2c952021-06-14WarningsExact identifier
spl id: c4bd3ffa-9a36-894e-e053-2995a90a2c95
spl set id: c4bd3ffa-9a35-894e-e053-2995a90a2c95

Reported adverse events (FAERS/openFDA)#

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