Walgreen Company

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

In the listing file submitted to FDA, the active ingredient list included in the labeling does not match the active ingredient list included in the electronic listing file in SPL. Specifically, the active ingredients described under the Drug Facts section and in the Principal Display Panel image of the labeling include potassium nitrate and sodium fluoride with the fluoride ion as the active moiety. However, the electronic listing file in SPL only includes sodium fluoride (with the active moiety of fluoride ion as the basis of strength).

Passage 2

According to the labeling, the quantity or strength of the active moiety, fluoride ion, the basis of strength, does not match the strength included in the SPL. Specifically, according to the labeling the strength of the fluoride ion as the active moiety is “0.15 gm in 100 gm,” however, strength in the SPL for the fluoride ion, which is listed to be the basis of strength, is stated as “0.24 g in 100 g.” This strength corresponds to the strength of the sodium fluoride in the labeling, not to the strength of the fluoride ion for the listed product.