BRISA AWAKEN REFRESHED- sodium fluoride paste, dentifrice 
The Procter & Gamble Manufacturing Company

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.

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Brisa Awaken Refreshed

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-443
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SORBITOL (UNII: 506T60A25R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MICA (UNII: V8A1AW0880)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-443-411 in 1 CARTON10/21/201908/21/2021
1116 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/21/201908/21/2021
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 10/2022
 
The Procter & Gamble Manufacturing Company