FDA Registration for First Aid Antiseptic Products

First aid antiseptic products are regulated as OTC Monograph drugs by FDA.

OTC MonographDrug Facts Labeling21 CFR Part 207Since 2009

FDA Requirements for First aid Antiseptic Products

First aid antiseptic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each condition in the OTC monograph.

FDA Drug Establishment Registration
NDC Labeler Code
Drug Listing with Drug Facts labeling
Annual renewal October 1–December 31

The FDA established an OTC monograph specifically for First Aid Antiseptic drug products. This ensures these topical medications meet safety and effectiveness standards for helping prevent infection in minor cuts, scrapes, and burns. The monograph outlines requirements for things like ingredients, testing, and labeling. This helps consumers choose from a variety of first-aid antiseptic products with the confidence that they have been evaluated by the FDA for their intended use.

Active Ingredients	OTC Monograph Number
(a) Alcohol 48 to 95% by volume in an aqueous solution denatured	M003.10 (Part 333 )
(b) Alcohol 26.9% when combined with Eucalyptol 0.091% or Menthol 0.042% or Methyl salicylate 0.055% or Thymol 0.063%	M003.10 (Part 333 )
(c) Benzalkonium chloride 0.1 to 0.13%	M003.10 (Part 333 )
(d) Benzethonium chloride 0.1 to 0.2%	M003.10 (Part 333 )
(e) Camphorated metacresol (camphor 3 to 10.8% and metacresol 1 to 3.6% in a ratio of 3 parts camphor to 1 part metacresol)	M003.10 (Part 333 )
(f) Camphorated phenol (camphor 10.8% and phenol 4.7%) in a light mineral oil, USP vehicle	M003.10 (Part 333 )
(g) Eucalyptol 0.091% when combined	M003.10 (Part 333 )
(h) Hexylresorcinol 0.1%	M003.10 (Part 333 )
(i) Hydrogen peroxide topical solution USP	M003.10 (Part 333 )
(j) Iodine tincture USP	M003.10 (Part 333 )
(k) Iodine topical solution USP	M003.10 (Part 333 )
(l) Isopropyl alcohol 50 to 91.3% by volume in an aqueous solutio	M003.10 (Part 333 )
(m) Menthol 0.042% when combined	M003.10 (Part 333 )
(n) Methylbenzethonium chloride 0.13 to 0.5%	M003.10 (Part 333 )
(o) Methyl salicylate 0.055% when combined	M003.10 (Part 333 )
(p) Phenol 0.5 to 1.5%	M003.10 (Part 333 )
(q) Povidone-iodine 5 to 10%	M003.10 (Part 333 )
(r ) Thymol 0.063% when combined	M003.10 (Part 333 )

These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.