The type size is not negotiable. The bottle is.
The claim arrived after the bottles
Marketing writes "controls dandruff" on a product already packed in a 2 oz jar. The claim made it a drug and the drug needs a panel the jar cannot carry.
The designer asked for 5-point type
It is not available. The content floor is 6-point, headings are the larger of 8-point or two points over the text, and the title is larger than everything in the panel.
The 60 percent clause read as a general exemption
It gives a 7-point continuation title, headings one point over the text, tighter leading, unaligned bullets and the box dropped where contrast does the job. That is a point of relief, not a different panel.
Available label space confused with surface area
A bottle's surface includes its shoulder, its taper and its base. The label space is the part a label can actually sit on without lifting.
A tapered bottle chosen for its look
And then measured. A cosmo oval or a tapered round gives far less usable wrap than its capacity suggests, which is why the packer bottle keeps winning this argument.
The monograph warnings counted as optional
They are not. "For external use only", the eye warning, the two referral warnings, and the sun warning for coal tar all appear, and they are part of the area calculation.
The wash-off and leave-on distinction missed
Pyrithione zinc has different permitted ranges for a product that is rinsed and one that is not. A leave-in formulated at a wash-off concentration is outside the monograph.
The carton treated as a failure
It is the normal answer for a small drug product. A folding carton or a booklet label carries what a 30 mL bottle cannot, and it is cheaper than repackaging.
The order that avoids all of this
Decide the claim, typeset the panel, measure it, then choose the container. Four steps, in that order, and none of them is expensive.
And keep the claim under review
A cosmetic that acquires a treatment claim in its second year has become a different regulated product, and the label it was printing is no longer the right one.
References
21 CFR 201.66(d), the Drug Facts format. The title "Drug Facts" "shall appear in a type size larger than the largest type size used in the Drug Facts labeling". Headings are set at "the larger of either 8-point or greater type, or 2-point sizes greater than the point size of the text", and all other content is "no smaller than 6-point type". Paragraph (d)(10) relaxes the format where the Drug Facts labeling would occupy more than 60 percent of the available label space: a continuation title at no smaller than 7-point, headings at the larger of 7-point or one point over the text, reduced leading provided ascenders and descenders do not touch, bullets that need not be vertically aligned, and the enclosing box omitted where color contrast distinguishes the labeling.
law.cornell.edu21 CFR 358.750, labeling. The statement of identity is "[Dandruff] (insert product form)" or "antidandruff (insert product form)", with the equivalent forms for seborrheic dermatitis and psoriasis. The indication is "(For relief of or Controls) the symptoms of" the condition. The general warnings are "For external use only" and "Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water". Coal tar carries "Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours". Both "If condition worsens or does not improve after regular use of this product as directed, consult a doctor" and "Do not use for prolonged periods without consulting a doctor" appear. Directions for a wash-off product are "For best results use at least twice a week or as directed by a doctor"; for a leave-on, "Apply to affected areas one to four times daily or as directed by a doctor".
law.cornell.edu21 CFR 358.710, active ingredients of the dandruff, seborrheic dermatitis and psoriasis monograph. For dandruff: coal tar 0.5 to 5 percent; pyrithione zinc 0.3 to 2 percent in a wash-off formulation and 0.1 to 0.25 percent leave-on; salicylic acid 1.8 to 3 percent; selenium sulfide 1 percent and micronized selenium sulfide 0.6 percent; sulfur 2 to 5 percent. For seborrheic dermatitis: coal tar 0.5 to 5 percent; pyrithione zinc 0.95 to 2 percent wash-off and 0.1 to 0.25 percent leave-on; salicylic acid 1.8 to 3 percent; selenium sulfide 1 percent. For psoriasis: coal tar 0.5 to 5 percent; salicylic acid 1.8 to 3 percent.
law.cornell.edu 