StacksVerified U.S. regulatory reference

21 CFR §346.10

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient:
  1. (a)Benzocaine 5 to 20 percent.
  2. (b)Benzyl alcohol 1 to 4 percent.
  3. (c)Dibucaine 0.25 to 1 percent.
  4. (d)Dibucaine hydrochloride 0.25 to 1 percent.
  5. (e)Dyclonine hydrochloride 0.5 to 1 percent.
  6. (f)Lidocaine 2 to 5 percent.
  7. (g)Pramoxine hydrochloride 1 percent.
  8. (h)Tetracaine 0.5 to 1 percent.
  9. (i)Tetracaine hydrochloride 0.5 to 1 percent.