Colgate Anticavity Kit

Manufacturer
Yangzhou Huayin Tourist Daily Necessities Co.,LTD | Colgate-Palmolive (Thailand) Limited - Branch
Effective date
2020-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:36:08

Label at a glance#

ProductColgate Anticavity Kit
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 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

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children 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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-468-6502

PRINCIPAL DISPLAY PANEL - 5g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN3
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73181-166-882022-01-28C16284748780-1d6a99b39-b5c0-a426-e053-dadaa90af4c2Anticavity Toothpaste Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73181-166-88Colgate Anticavity Kit1 in 1 PACKAGEPASTE, DENTIFRICE13
73181-166-88Colgate Anticavity Kit5 g in 1 TUBEPASTE, DENTIFRICE53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73181-166COLGATE ANTICAVITY KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [YANGZHOU HUAYIN TOURIST DAILY NECESSITIES CO.,LTD]3Legacy NDC, 2 package rows20201231_8a270893-25ad-98b7-e053-2a95a90a980e.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73181-16673181-166-88

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
b7a45b64-4b2f-431e-e053-2995a90a762e8a270893-25ad-98b7-e053-2a95a90a980e2020-12-29WarningsExact identifier
spl id: b7a45b64-4b2f-431e-e053-2995a90a762e
spl set id: 8a270893-25ad-98b7-e053-2a95a90a980e

Reported adverse events (FAERS/openFDA)#

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