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Drug Facts

Type sizes

On this page11
Three rules, and none of them bends for a small bottle unless the 60 percent clause applies.

The title

"Drug Facts" "shall appear in a type size larger than the largest type size used in the Drug Facts labeling". So it scales with your panel rather than sitting at a fixed size.

The headings

"The larger of either 8-point or greater type, or 2-point sizes greater than the point size of the text". Which means setting the body larger pushes the headings up too.

The content

"No smaller than 6-point type" for everything else. That is the floor and it is the number to measure your label area against.

Six point is small

And it is still a real amount of space once you have the identity, the indication, five warnings, the directions and the inactive ingredients in a structured panel with rules and headings.

The panel has a structure, not just a size

Headings in a set order, bullets, barlines and an enclosing box. The format is part of the requirement and it costs area beyond the words themselves.

Which is why it has to be laid out to be measured

A word count does not tell you whether a panel fits. A typeset panel at 6-point with its box and barlines does, and it takes an afternoon.

Then measure your container

Label area is a measurable property of a bottle: the printable height and the circumference you can wrap without the label lifting. Get it from the drawing rather than estimating.

Cylindrical containers are the easy case

A straight wall takes a wrap label and the whole circumference is usable. A tapered bottle, a cosmo oval or a jar with a shoulder gives you much less than its size suggests.

Which is an argument for the packer bottle

81 PET packers and 46 HDPE packers on this shelf. Straight wall, wide shoulder, generous label panel, and the format most able to carry a Drug Facts panel at a usable size.

And against the double wall jar

22 round base and 15 straight base double wall jars. They look expensive and they give you an outer wall to label and a volume penalty. Fine for a cosmetic mask, awkward for a drug.

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.edu
The Davis Pack Supply catalog, measured 18 October 2026. The hair care shelf is 1,261 rows: 628 containers and 633 closures. 5 mL to 2,000 mL with a median of 237; 370 containers over 6 oz, 330 over 8 oz, 187 over 16 oz and 54 over 32 oz. 342 PET, 110 glass, 94 HDPE, 73 PP, 9 steel. 349 bottles, 260 jars, 9 tins, 5 tubs and pails, 3 jugs and 2 tubes. Closures: 384 continuous thread, 43 dropper assemblies, 39 lotion pumps, 27 dome lids, 26 disc top, 16 flip top, 14 phenolic, 12 lug and twist, 11 treatment pumps, 9 round tubs, 7 buttress. Necks: 86 at 89-400, 70 at 38-400, 59 at 24-410, 58 at 70-400, 51 at 28-410, 42 at 45-400.
Written from 21 CFR part 358 subpart H, 21 CFR 201.66 and the catalog as it stood on 18 October 2026. Whether a particular product is a cosmetic or a drug turns on its intended use, which is established by what you say about it; no page here can make that determination for you. Cosmetic labeling, facility registration and product listing are covered in the grooming property and not repeated.