Using Sodium Bicarbonate in Mouthwash and FDA Regulations

Using Sodium Bicarbonate in Mouthwash

Yes, Sodium Bicarbonate can be used in mouthwash formulations. It is a popular ingredient in oral care due to its ability to neutralize acids in the mouth, which helps prevent tooth decay and reduces bad breath.

1. Thai FDA Regulations and Usage Levels

• Sodium Bicarbonate: There is no specific maximum limit set by the Thai FDA (following ASEAN Cosmetic Directive) for Sodium Bicarbonate in mouthwash. It is generally considered safe. However, for practical formulation and taste:
  • Recommended level: 0.5% - 2.0% is typical for daily mouthwash.
  • Solubility: It can dissolve in water up to approximately 9%. Using too much may result in a salty or soapy taste.
• Sodium Fluoride: As previously discussed, the Thai FDA limits the concentration of Fluoride in oral products to not exceed 0.15% (calculated as Fluorine). If you use Sodium Fluoride (anti-caries, oral care), this equates to approximately 0.33% of the raw material, but most daily mouthwashes use around 0.05% Sodium Fluoride for safety and efficacy.

2. Benefits of Combining Sodium Bicarbonate and Sodium Fluoride

Using these two ingredients together is highly effective:

• Acid Neutralization: Sodium Bicarbonate raises the pH of the mouth, neutralizing acids produced by bacteria that cause enamel erosion.
• Enhanced Remineralization: Fluoride works best in a non-acidic environment. By neutralizing acids, Sodium Bicarbonate creates an optimal environment for Sodium Fluoride to remineralize tooth enamel.
• Cleaning: It helps remove biofilm and stains gently.

3. Formulation Tips

• pH Control: Sodium Bicarbonate will make the formula alkaline (pH approx. 8.0-8.5). Ensure your other ingredients (like preservatives or flavors) are stable at this pH.
• Mixing: Dissolve Sodium Bicarbonate and Sodium Fluoride in the water phase until completely clear before adding other components.

Recommended Products:

• Sodium Bicarbonate: High purity grade suitable for pH adjustment and oral care.
• Sodium Fluoride (anti-caries, oral care): Specifically for preventing cavities in oral hygiene products.