Anorectal Drugs
The FDA has an established OTC monograph, M015, specifically for Anorectal Drug Products. This means certain medications for hemorrhoids and other anal discomfort are recognized as safe and effective for over-the-counter sale if they meet the requirements outlined in the monograph. These requirements include the type of ingredients, how the medication is applied (topical or rectal), and the labeling information. The monograph ensures a consistent level of safety and efficacy for these commonly used products.
M015.10 Local anesthetic active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
| Benzocaine 5 to 20 percent | M015.10 (Part 346) |
| Benzyl alcohol 1 to 4 percent | M015.10 (Part 346) |
| Dibucaine 0.25 to 1 percent | M015.10 (Part 346) |
| Dibucaine hydrochloride 0.25 to 1 percent | M015.10 (Part 346) |
| Dyclonine hydrochloride 0.5 to 1 percent | M015.10 (Part 346) |
| Lidocaine 2 to 5 percent | M015.10 (Part 346) |
| Pramoxine hydrochloride 1 percent | M015.10 (Part 346) |
| Tetracaine 0.5 to 1 percent | M015.10 (Part 346) |
| Tetracaine hydrochloride 0.5 to 1 percent | M015.10 (Part 346) |
M015.12 Vasoconstrictor active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
| Ephedrine sulfate 0.1 to 1.25 percent | M015.12 (Part 346) |
| Epinephrine 0.005 to 0.01 percent | M015.12 (Part 346) |
| Epinephrine hydrochloride 0.005 to 0.01 percent | M015.12 (Part 346) |
| Phenylephrine hydrochloride 0.25 percent | M015.12 (Part 346) |
M015.14 Protectant active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
| Aluminum hydroxide gel | M015.14 (Part 346) |
| Cocoa butter | M015.14 (Part 346) |
| Glycerin in a 20 to 45-percent (weight/weight) | M015.14 (Part 346) |
| Hard fat | M015.14 (Part 346) |
| Kaolin | M015.14 (Part 346) |
| Lanolin | M015.14 (Part 346) |
| Mineral oil | M015.14 (Part 346) |
| Petrolatum | M015.14 (Part 346) |
| Topical starch | M015.14 (Part 346) |
| White petrolatum | M015.14 (Part 346) |
| Calamine not to exceed 25 percent by weight per dosage unit | M015.14 (Part 346) |
| Cod liver oil | M015.14 (Part 346) |
| Shark liver oil | M015.14 (Part 346) |
| Zinc oxide not to exceed 25 percent by weight per dosage unit | M015.14 (Part 346) |
M015.16 Analgesic, anesthetic, and antipruritic active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
| Camphor 0.1 to 3 percent | M015.16 (Part 346) |
| Juniper tar 1 to 5 percent | M015.16 (Part 346) |
| Menthol 0.1 to 1 percent | M015.16 (Part 346) |
M015.18 Astringent active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
| Calamine, within a concentration range of 5 to 25 percent by weight per dosage unit | M015.18 (Part 346) |
| Witch hazel, 10 to 50 percent | M015.18 (Part 346) |
| Zinc oxide, within a concentration range of 5 to 25 percent by weight per dosage unit | M015.18 (Part 346) |
M015.20 Keratolytic active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
| Alcloxa 0.2 to 2 percent | M015.20 (Part 346) |
| Resorcinol 1 to 3 percent | M015.20 (Part 346) |
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.
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