SENSODYNE PRONAMEL  INTENSIVE ENAMEL REPAIR EXTRA FRESH- sodium fluoride liquid 
SENSODYNE PRONAMEL  INTENSIVE ENAMEL REPAIR CLEAN MINT- sodium fluoride liquid 
Haleon US Holdings LLC

----------

Drug Facts

Active ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity

Uses

• aids in the prevention of dental cavities.

• the combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.

Warning

Keep Out of Reach of Children.If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 6 years of age and older:

  1. • use once a day after brushing your teeth with a toothpaste.
  2. • pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above the 10 mL mark.
  3. • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.
  4. • do not swallow the rinse.
  5. • do not drink from the bottle.
  6. • do not rinse mouth with water.
  7. • do not eat or drink for 30 minutes after rinsing.
  8. • instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
  9. • supervise children as necessary until capable of using without supervision.

children under 6 years of age:Consult a dentist or doctor.

Other information

• do not store above 25°C (77°F)

Inactive ingredients (Clean Mint)

water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate

Inactive ingredients (Extra Fresh)

water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate, FD&C blue no. 1

Questions or comments?

1-866-844-2797

Other Information

Re-mineralizing action for strong and protected teeth*

ALWAYS FOLLOW THE LABEL

Do not use if printed safety seal around cap is broken or missing.

*when used as directed with a fluoride toothpaste
**contains no ethanol

Distributed by: Haleon, Warren, NJ 07059
Trademarks are owned or licensed to the Haleon group of companies. ©2023 Haleon group of companies or its licensor.

Made in Taiwan

Principal Display Panel (Clean Mint)

New

SENSODYNE

PRONAMEL

ANTICAVITY FLUORIDE MOUTHWASH

INTENSIVE ENAMEL

REPAIR

CLEAN MINT

Cavity
Protection

Alcohol
Free**

Helps actively repair weakened enamel*

IMPORTANT: Read directions for proper use

16.9 FL OZ (500 mL)

Front: 204828

Back: 204832

Sensodyne Pro Inten Enamel Repair Clean Mint 500 mL

Principal Display Panel (Extra Fresh)

New

SENSODYNE

PRONAMEL

ANTICAVITY FLUORIDE MOUTHWASH

INTENSIVE ENAMEL

REPAIR

EXTRA FRESH

Cavity
Protection

Alcohol
Free**

Helps actively repair weakened enamel*

IMPORTANT: Read directions for proper use

16.9 FL OZ (500 mL)

Front: 204830

Back: 204831

Sensodyne Pro Inten Enamel Repair Extra Fresh 500 mL
SENSODYNE PRONAMEL   INTENSIVE ENAMEL REPAIR EXTRA FRESH
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0451
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0451-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/02/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02201/02/2024
SENSODYNE PRONAMEL   INTENSIVE ENAMEL REPAIR CLEAN MINT
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0449
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0449-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/02/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02201/02/2024
Labeler - Haleon US Holdings LLC (079944263)

Revised: 4/2024
Document Id: 15b07287-bce2-aa6f-e063-6394a90a8da7
Set id: 817c0dad-d109-428e-adb5-3354604acc94
Version: 2
Effective Time: 20240409
 
Haleon US Holdings LLC