Japan Adjust Concentration Limit of Fluoride Used In Medicated Toothpaste

Takehome:

The permitted maximum concentration of fluoride used in medicated toothpaste (except for liquid form) in Japan has been raised to 1500ppm (previously 1000ppm). Toothpaste with fluoride (concentration surpass 1000ppm and below 1500ppm) will be treated as a quasi drug.

For toothpaste with more than 1000ppm concentration of fluoride, special claims should be attached on labels or containers. Claims include precaution for children and description of concentration, which will be outlined below.

Precaution for children:

The following claims should be stated on direct container or on the package. If there is no description space, the second one could be omitted.

1. Refrain from use in children under 6 years old
2. Keep it in a place out of reach of children under 6 years old.

Description of concentration:

The description of concentration should be stated on direct container or on the package. It can either be stated with the precaution for use in children or stated separately.