OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT
Sodium Fluoride .34%
COLGATE TRILPLE ACCION
- Manufacturer
- GENESIS IMPORTS & EXPORTS LLC | TERESA CECENA | MISSION HILLS SA DE CV
- Effective date
- 2017-04-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:49:36
Label at a glance#
ProductCOLGATE TRILPLE ACCION
Active ingredientSODIUM FLUORIDE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
PURPOSE
Anticanity
USER SAFETY WARNINGS SECTION
USE
Helps protect against cavities
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE. If more that used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.
WARNINGS SECTION
Keep outh of the reach of children under 6 years of age. if more than the used for brushing is accidentally swallowed, get medical help or contact a poison control center rigth away
INDICATIONS & USAGE SECTION
Directions
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: use only a pea sized amount and supervise child's brushing and rising ( to minimize swallowing)
children under 2 years L ask a dentist or physician
INACTIVE INGREDIENT SECTION
water, hydrated silica, blue, sodium lauryl sulfate, cellusosa gum, sacchharin sodium, xanathan gum, titanium dioxide, glycerin, aroma,green #7, eugenol
DOSAGE & ADMINISTRATION SECTION
Directions
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: use only a pea sized amount and supervise child's brushing and rising ( to minimize swallowing)
children under 2 years L ask a dentist or physician
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69772-105-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0600-f424-e053-dadaa90a57ce | 4d648add-ae39-3716-e054-00144ff88e88 |
| 69772-105-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0600-f424-e053-dadaa90a57ce | 4d648add-ae39-3716-e054-00144ff88e88 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69772-105-01 | COLGATE TRILPLE ACCION | 150 mL in 1 TUBE | PASTE, DENTIFRICE | 150 | 1 | |
| 69772-105-01 | COLGATE TRILPLE ACCION | 4 in 1 PACKAGE | PASTE, DENTIFRICE | 4 | 1 | |
| 69772-105-02 | COLGATE TRILPLE ACCION | 150 mL in 1 TUBE | PASTE, DENTIFRICE | 150 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- COLGATE TRILPLE ACCION
- SODIUM FLUORIDE
- SODIUM LAURYL SULFATE
- FLUORIDE ION
- XANTHAN GUM
- GLYCERIN
- HYDRATED SILICA
- WATER
- FD&C BLUE NO. 1
- SACCHARIN SODIUM
- TITANIUM DIOXIDE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- PIGMENT GREEN 7
- EUGENOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69772-105 | 69772-105-01, 69772-105-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| XANTHAN GUM | TTV12P4NEE | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| WATER | 059QF0KO0R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| PIGMENT GREEN 7 | BPO9294G4W | IACT |
| EUGENOL | 3T8H1794QW | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4d648add-ae3a-3716-e054-00144ff88e88 | 4d648add-ae39-3716-e054-00144ff88e88 | 2017-04-17 | Warnings | 4d648add-ae3a-3716-e054-00144ff88e88 4d648add-ae39-3716-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.