up and up anticavity toothpaste multi-function

up and up anticavity toothpaste multi-function
SPL v1
SPL
SPL Set ID eef7c016-0b43-41cc-8dc5-2e95393f2544
Route
dental
Published
Effective Date 2010-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (4.54 mg)
Inactive Ingredients
sorbitol water silicon dioxide sodium polymetaphosphate glycerin sodium lauryl sulfate zinc lactate polyethylene glycol 300 croscarmellose sodium sodium phosphate sodium gluconate saccharin sodium titanium dioxide fd&c blue no. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
otc monograph final active Since 2010-08-25
Description

STANNOUS FLUORIDE 0.454%......................  ANTICAVITY, ANTIGINGIVITIS, (0.16% W/V FLUORIDE ION)                             ANTISENSITIVITY TOOTHPASTE 

Medication Information

Warnings
WARNINGS: WHEN USING THIS PRODUCT DO NOT USE FOR SENSITIVITY LONGER THAN FOUR WEEKS UNLESS RECOMMENDED BY A DENTIST. STOP USE AND ASK A DENTIST IF THE SENSITIVITY PROBLEM PERSISTS OR WORSENS. SENSITIVE TEETH MAY INDICATE A SERIOUS PROBLEM THAT MAY NEED PROMPT CARE. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Uses
  • HELPS AID IN THE PREVENTION OF CAVITIES

  • HELPS PREVENT GINGIVITIS

  • HELPS CONTROL PLAQUE BACTERIA THAT CONTRIBUTE TO THE DEVELOPMENT OF GINGIVITIS
  • BUILD INCREASING PROTECTION AGAINST PAINFUL SENSITIVITY OF THE TEETH TO COLD, HEAT, ACIDS, SWEETS OR CONTACT.

Directions

Adults and children 12 years and older     Brush teeth thoroughly, PREFERABLY AFTER EACH MEAL,or at least twice a day,                                                                       or as directed by your dentist. DO NOT SWALLOW

Children under 12                                         ASK A dentist or PHYSICIAN

Other information                                         PRODUCTS CONTAINING STANNOUS FLUORIDE MAY PRODUCE SURFACE                                                                               STAINING OF THE TEETH. ADEQUATE TOOTHBRUSHING MAY PREVENT                                                                                   THESE STAIN WHICH ARE NOT HARMFUL OR PERMANENT.

Description

STANNOUS FLUORIDE 0.454%......................  ANTICAVITY, ANTIGINGIVITIS, (0.16% W/V FLUORIDE ION)                             ANTISENSITIVITY TOOTHPASTE 

Principal Display Panel


Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 55105-1

ANTICAVITY, ANTIGINGIVITIS, ANTISENSITIVITY TOOTHPASTE

Active Ingredients

STANNOUS FLUORIDE 0.454%......................  ANTICAVITY, ANTIGINGIVITIS,

(0.16% W/V FLUORIDE ION)                             ANTISENSITIVITY TOOTHPASTE 

Inactive Ingredients:
Sorbitol, Water, HYDRATED SILICA, SODIUM HEXAMETAPHOSPHATE, Glycerin, SODIUM LAURYL SULPHATE, flavor, ZINC LACTATE, PEG-6, CELLULOSE GUM, SODIUM PHOSPHATE, SODIUM GLUCONATE, Sodium Saccharin, Titanium Dioxide, BLUE 1, YELLOW 4.

Structured Label Content

Warnings (WARNINGS)
WARNINGS: WHEN USING THIS PRODUCT DO NOT USE FOR SENSITIVITY LONGER THAN FOUR WEEKS UNLESS RECOMMENDED BY A DENTIST. STOP USE AND ASK A DENTIST IF THE SENSITIVITY PROBLEM PERSISTS OR WORSENS. SENSITIVE TEETH MAY INDICATE A SERIOUS PROBLEM THAT MAY NEED PROMPT CARE. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Uses (USES)
  • HELPS AID IN THE PREVENTION OF CAVITIES

  • HELPS PREVENT GINGIVITIS

  • HELPS CONTROL PLAQUE BACTERIA THAT CONTRIBUTE TO THE DEVELOPMENT OF GINGIVITIS
  • BUILD INCREASING PROTECTION AGAINST PAINFUL SENSITIVITY OF THE TEETH TO COLD, HEAT, ACIDS, SWEETS OR CONTACT.

Directions

Adults and children 12 years and older     Brush teeth thoroughly, PREFERABLY AFTER EACH MEAL,or at least twice a day,                                                                       or as directed by your dentist. DO NOT SWALLOW

Children under 12                                         ASK A dentist or PHYSICIAN

Other information                                         PRODUCTS CONTAINING STANNOUS FLUORIDE MAY PRODUCE SURFACE                                                                               STAINING OF THE TEETH. ADEQUATE TOOTHBRUSHING MAY PREVENT                                                                                   THESE STAIN WHICH ARE NOT HARMFUL OR PERMANENT.

Principal Display Panel


Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 55105-1 (55105-1)

ANTICAVITY, ANTIGINGIVITIS, ANTISENSITIVITY TOOTHPASTE

Active Ingredients

STANNOUS FLUORIDE 0.454%......................  ANTICAVITY, ANTIGINGIVITIS,

(0.16% W/V FLUORIDE ION)                             ANTISENSITIVITY TOOTHPASTE 

Inactive Ingredients: (Inactive ingredients:)
Sorbitol, Water, HYDRATED SILICA, SODIUM HEXAMETAPHOSPHATE, Glycerin, SODIUM LAURYL SULPHATE, flavor, ZINC LACTATE, PEG-6, CELLULOSE GUM, SODIUM PHOSPHATE, SODIUM GLUCONATE, Sodium Saccharin, Titanium Dioxide, BLUE 1, YELLOW 4.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:07.238444 · Updated: 2026-03-14T22:52:27.184723