OTC Medication Information: Brisa Awaken Refreshed

BRISA AWAKEN REFRESHED- sodium fluoride paste, dentifrice
Haney, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Sodium fluoride 0.243%

(0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

helps protect against cavities

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.

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

Questions?

1-888-654-6409

DISTR. BY/POR AGILE PURSUITS

CINCINNATI, OH 45202

116g tube in carton

brisa™

TOOTHPASTE

flouride toothpaste

Awaken Refreshed

NET WT 4.1OZ (116g) 943

BRISA AWAKEN REFRESHED
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73378-002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOXYPOLYMETHYLENE
POLYSORBATE 80
HYDRATED SILICA
TITANIUM DIOXIDE
CARBOXYMETHYLCELLULOSE SODIUM
SORBITOL
SACCHARIN SODIUM (SACCHARIN)
SODIUM LAURYL SULFATE
SODIUM HYDROXIDE
SODIUM ACID PYROPHOSPHATE
WATER
FD&C BLUE NO. 1
MICA
Product Characteristics
Color blue Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73378-002-41 1 TUBE in 1 CARTON contains a TUBE
1 116 g in 1 TUBE This package is contained within the CARTON (73378-002-41)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 10/21/2019
Labeler — Haney, Inc. (788699445)

Revised: 10/2019 Haney, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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