Pain-relief creams under the FDA's OTC monograph

The monograph is short and specific, and most label problems start with it. This guide covers the parts a brand needs before briefing a formulator. The strengths below come from the monograph as the FDA posted it on May 2, 2023 (FDA: OTC Monograph M017). Check the current version before you file.

Two kinds of active ingredient

M017 splits pain-relief actives into two groups. Analgesics, anesthetics, and antipruritics act on pain or itch in the skin where they are applied. Counterirritants create a cooling, warming, or reddening sensation that eases aches in the muscles and joints underneath. The group decides the uses and warnings the label carries.

Common actives and their strengths

Smaller amounts of menthol (0.1 to 1%) and camphor (0.1 to 3%) count as analgesics rather than counterirritants, which changes the label. Formulas with more than one active are limited to the pairings in the monograph's combinations section, so check a multi-active formula against that list too.

What the label can say

The uses on a monograph product come from a short list. A counterirritant rub may say it is “for the temporary relief of minor aches and pains of muscles and joints,” optionally followed by “associated with” simple backache, arthritis, strains, bruises, or sprains.

An anesthetic or analgesic cream may say it is for the temporary relief of pain, itching, or both, optionally associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations. Other truthful statements are allowed only when they describe those same uses.

Counterirritant products may also use a few extra phrases, such as “cooling pain relief” or “warming pain relief,” as long as those phrases are not placed beside the required information or given more prominence than it.

Lidocaine has a ceiling

Lidocaine is allowed at 0.5 to 4%. A product above 4% is outside the monograph and would need an approved application to be sold. The FDA has sent warning letters to sellers of 5% lidocaine products on this point (March 2024 letter, February 2025 letter).

The same letters make a second point. Indications related to tattooing, piercing, and laser cosmetic procedures are not part of M017. A 4% lidocaine cream labeled for minor burns, cuts, and scrapes fits the monograph, and the same cream marketed for a procedure falls outside it.

Warnings every label carries

Every M017 cream carries “For external use only” and “Avoid contact with the eyes,” plus an instruction to stop use and ask a doctor if the condition worsens or symptoms last more than seven days. Counterirritant rubs add “Do not apply to wounds or damaged skin” and “Do not bandage tightly.” Lidocaine products add “Do not use in large quantities, particularly over raw surfaces or blistered areas.”

What this means for a brand

• Pick the active and the strength from the monograph first, then build the formula around them.
• Write the uses in the monograph's wording, and keep the website and ads inside them.
• Make the cream at a facility registered for OTC drugs, list it with the FDA, and print a Drug Facts panel.
• Expect the active ingredient to be tested on every batch, with stability data behind the expiration date.

We make OTC pain-relief creams to this monograph at registered US facilities, for US brands and for brands elsewhere that sell in the US. See cream manufacturing for formats, packaging, and minimums.