brisa awaken refreshed

brisa awaken refreshed
SPL v1
SPL
SPL Set ID 946c8b37-7d85-4c5b-e053-2995a90ac8ed
Route
oral
Published
Effective Date 2019-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.5 mg)
Inactive Ingredients
carboxypolymethylene polysorbate 80 hydrated silica titanium dioxide carboxymethylcellulose sodium sorbitol saccharin sodium lauryl sulfate sodium hydroxide sodium acid pyrophosphate water fd&c blue no. 1 mica

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
otc monograph final active Since 2019-10-21
Purpose

Anticavity toothpaste

Description

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Medication Information

Purpose

Anticavity toothpaste

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist
Inactive Ingredients

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, sodium saccharin, carbomer, polysorbate 80, mica, titanium dioxide, blue 1

Description

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Questions?

1-888-654-6409

Use

helps protect against cavities

Section 42229-5

DISTR. BY/POR AGILE PURSUITS

CINCINNATI, OH 45202

Warning

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Drug Facts

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)

116g Tube in Carton

brisa™

TOOTHPASTE

flouride toothpaste

Awaken Refreshed

NET WT 4.1OZ (116g)

Structured Label Content

Purpose

Anticavity toothpaste

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist
Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, sodium saccharin, carbomer, polysorbate 80, mica, titanium dioxide, blue 1

Questions?

1-888-654-6409

Use

helps protect against cavities

Section 42229-5 (42229-5)

DISTR. BY/POR AGILE PURSUITS

CINCINNATI, OH 45202

Warning

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Drug Facts

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)

116g Tube in Carton (116g tube in carton)

brisa™

TOOTHPASTE

flouride toothpaste

Awaken Refreshed

NET WT 4.1OZ (116g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:54.942471 · Updated: 2026-03-14T22:55:42.107827