Oral Health Care Products
The FDA establishes guidelines for over-the-counter (OTC) oral health care drugs through a document called an OTC monograph. This monograph outlines the conditions under which these medications are considered safe and effective for their intended use. Essentially, it sets the standards that OTC oral care products must meet to be sold over the counter without a prescription. The monograph covers various purposes, including pain relief, antiseptic properties, and reduction of plaque and gingivitis. Following this guideline helps ensure that consumers have access to safe and effective oral care products for common concerns.
Oral Health Care Products - Active Ingredients and OTC Monograph Number
M022.12 Anesthetic/analgesics| Active Ingredients | OTC Monograph Number |
|---|---|
| Benzocaine | M022.12 (Part 356) |
| Benzyl alcohol | M022.12 (Part 356) |
| Butacaine sulfate | M022.12 (Part 356) |
| Dyclonine hydrochloride | M022.12 (Part 356) |
| Hexylresorcinol | M022.12 (Part 356) |
| Menthol | M022.12 (Part 356) |
| Phenol preparations (phenol and/or phenolate sodium) | M022.12 (Part 356) |
| Salicyl alcohol | M022.12 (Part 356) |
| Active Ingredients | OTC Monograph Number |
|---|---|
| Alum | M022.14 (Part 356) |
| Zinc chloride | M022.14 (Part 356) |
| Active Ingredients | OTC Monograph Number |
|---|---|
| Carbamide peroxide in anhydrous glycerin | M022.16 (Part 356) |
| Hydrogen peroxide | M022.16 (Part 356) |
| Sodium bicarbonate | M022.16 (Part 356) |
| Sodium perborate monohydrate | M022.16 (Part 356) |
| Active Ingredients | OTC Monograph Number |
|---|---|
| Elm bark | M022.18 (Part 356) |
| Gelatin | M022.18 (Part 356) |
| Glycerin | M022.18 (Part 356) |
| Pectin | M022.18 (Part 356) |
| Active Ingredients | OTC Monograph Number |
|---|---|
| Compound benzoin tincture, USP XIX.3 | M022.20 (Part 356) |
| Benzoin tincture, USP XV | M022.20 (Part 356) |
| Active Ingredients | OTC Monograph Number |
|---|---|
| Potassium nitrate | M022.22 (Part 356) |
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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