Gosmile (as Pld) - Luxury Toothpaste, Am (44873-106)

Gosmile (as Pld) - Luxury Toothpaste, Am (44873-106)
SPL v4
SPL
SPL Set ID 68f24abb-19b0-4dbd-aac0-9fd6dada1531
Route
ORAL
Published
Effective Date 2020-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.13 g)
Inactive Ingredients
Sorbitol Water Hydrated Silica Glycerin Sodium Lauryl Sulfate Carboxymethylcellulose Titanium Dioxide Sodium Benzoate Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-10-27
Description

SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% w/v FLUORIDE ION)

Purpose

ANTICAVITY

Medication Information

Warnings and Precautions

IF MORE THAN USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. 

Purpose

ANTICAVITY

Description

SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% w/v FLUORIDE ION)

Uses

AIDS IN THE PREVENTION OF DENTAL CAVITIES.

Section 51945-4

Warnings

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD.

Directions
  • ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: BRUSH TEETH THOROUGHLY FOR TWO MINUTES AT LEAST TWICE A DAY PREFERABLY AFTER EACH MEAL OR AS DIRECTED BY A DOCTOR OR DENTIST. THIS PRODUCT SHOULD BE USED AS PART OF AN ORAL HEALTH PROGRAM THAT INCLUDES REGULAR FLOSSING AND DENTAL CHECK-UPS.
  • 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 TWO YEARS OF AGE: CONSULT A DENTIST OR A DOCTOR.
Other Information

STORE AT ROOM TEMPERATURE.

Active Ingredients

SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% w/v FLUORIDE ION)

Inactive Ingredients

SORBITOL, PURIFIED WATER, HYDRATED SILICA, GLYCERIN, SODIUM LAURYL SULFATE, FLAVOR, CELLULOSE GUM, TITANIUM DIOXIDE, SODIUM SACCHARIN, SODIUM BENZOATE.

Structured Label Content

Uses (USES)

AIDS IN THE PREVENTION OF DENTAL CAVITIES.

Warnings and Precautions (34071-1)

IF MORE THAN USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. 

Section 51945-4 (51945-4)

Purpose (PURPOSE)

ANTICAVITY

Warnings (WARNINGS)

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OLD.

Directions (DIRECTIONS)
  • ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: BRUSH TEETH THOROUGHLY FOR TWO MINUTES AT LEAST TWICE A DAY PREFERABLY AFTER EACH MEAL OR AS DIRECTED BY A DOCTOR OR DENTIST. THIS PRODUCT SHOULD BE USED AS PART OF AN ORAL HEALTH PROGRAM THAT INCLUDES REGULAR FLOSSING AND DENTAL CHECK-UPS.
  • 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 TWO YEARS OF AGE: CONSULT A DENTIST OR A DOCTOR.
Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE.

Active Ingredients (ACTIVE INGREDIENTS)

SODIUM MONOFLUOROPHOSPHATE 0.76% (0.13% w/v FLUORIDE ION)

Inactive Ingredients (INACTIVE INGREDIENTS)

SORBITOL, PURIFIED WATER, HYDRATED SILICA, GLYCERIN, SODIUM LAURYL SULFATE, FLAVOR, CELLULOSE GUM, TITANIUM DIOXIDE, SODIUM SACCHARIN, SODIUM BENZOATE.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:21.468745 · Updated: 2026-03-14T23:01:50.647319