First Aid Antiseptic

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 vehicleM003.10 (Part 333 )
(g) Eucalyptol 0.091% when combinedM003.10 (Part 333 )
(h) Hexylresorcinol 0.1%M003.10 (Part 333 )
(i) Hydrogen peroxide topical solution USPM003.10 (Part 333 )
(j) Iodine tincture USPM003.10 (Part 333 )
(k) Iodine topical solution USPM003.10 (Part 333 )
(l) Isopropyl alcohol 50 to 91.3% by volume in an aqueous solutioM003.10 (Part 333 )
(m) Menthol 0.042% when combinedM003.10 (Part 333 )
(n) Methylbenzethonium chloride 0.13 to 0.5%M003.10 (Part 333 )
(o) Methyl salicylate 0.055% when combinedM003.10 (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 combinedM003.10 (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.

Back to previous page

Popular Pages