Mint

Manufacturer
Kareway Product, Inc.
Effective date
2023-02-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:36:27

Label at a glance#

ProductMint
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure7 sections

Dosage and administration

Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician Children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). Children under 2 years ask a dentist or physician

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76% (0.15%w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Usage

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

Enter section text here

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

OTC - KEEP OUT OF REACH OF CHILDREN 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 years of age and older
brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
Children 2 to 6 years
use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
Children under 2 years
ask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium carbonate, sorbitol, water, silicon dioxide, glycerine, sodium lauryl sulfate, sodium carboxymethyl cellulose, methyl parahydroxybenzoate, aminocaproic acid, xylitol, sodium saccharin, DL-menthol, flavor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Enter section text here image of toothpaste cartonimage of toothpaste carton

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67510-011167510-0111-4, 67510-0111-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
f4ee88a8-bf3c-454f-e053-2a95a90ae2a156e93b67-6064-5ae2-e054-00144ff88e882023-02-17WarningsExact identifier
spl id: f4ee88a8-bf3c-454f-e053-2a95a90ae2a1
spl set id: 56e93b67-6064-5ae2-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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