TOOTHPASTE TYPE-2 (Fluoridated) IS 6356:2021

Method Ref.: IS 6356:2021 |TAT : 7 Days*
Required sample quantity : 300–500 g
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Description

Fluoridated Toothpaste (Type-2) is a dental hygiene product formulated to clean teeth, freshen breath, and prevent dental caries (tooth decay) through the inclusion of fluoride compounds. As per IS 6356:1993, this type of toothpaste must meet strict safety, efficacy, and quality parameters to ensure oral health benefits while being non-toxic and safe for daily use.

The fluoride content is controlled within a specified range to provide anticaries protection without causing fluorosis or enamel damage.

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Purpose of Testing

The purpose of testing Fluoridated Toothpaste Type-2 under IS 6356:1993 is to ensure the product is safe, effective, and compliant with Indian cosmetic and health standards for oral care. Since this toothpaste is used daily and involves systemic fluoride exposure, testing is critical to protect consumer health and validate product performance.

✅ Key Objectives of Testing:

  1. Ensure Fluoride Content is Within Safe Limits
    – To verify that the fluoride concentration (usually 1000–1500 ppm) is effective against cavities but does not exceed toxic thresholds, preventing risks like dental or skeletal fluorosis.
  2. Evaluate Anticaries Efficacy
    – To ensure the product provides clinically effective protection against dental caries, supporting its core therapeutic claim.
  3. Verify Heavy Metal Safety
    – To confirm the toothpaste is free from toxic metals like lead, mercury, and arsenic, which may pose serious health risks when used orally.
  4. Check for Microbiological Safety
    – To ensure the product is free from harmful bacteria and fungi, maintain hygiene and prevent oral infections.
  5. Assess pH and Enamel Compatibility
    – To verify that the product has a safe pH level that does not erode tooth enamel or irritate oral mucosa.
  6. Test Abrasively and Cleaning Action
    – To confirm the toothpaste offers effective plaque and stain removal without being overly abrasive, preserving enamel integrity.
  7. Evaluate Stability and Shelf Life
    – To ensure the fluoride remains chemically stable and the toothpaste maintains uniform texture and performance over time.
  8. Support BIS and Regulatory Compliance
    – To meet legal labelling, composition, and safety norms, allowing for certified sale and consumer trust in India.

 

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