Monistat is an approved Over The Counter (OTC) Drug and safe to use.

Monistat is an over-the-counter antifungal medication commonly used to treat vaginal yeast infections. It contains the active ingredient miconazole, which works by stopping the growth of yeast causing the infection. Monistat is available in various forms, including creams, ointments etc. 

Recently, social media users have raised their voices against the use of Monistat as they claim it to be harmful for humans leading to burning, itching, abdominal cramping, headaches, hives, rashes etc.

However, Fact Crescendo found the claim to be misleading. Monistat is a FDA approved over the counter drug. All the ingredients used in Monistat meet safety standards. 

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Fact Check- 

A keyword search on Google led us to the evaluation of Monistat containing Miconazole Nitrate 1200mg by the FDA. The FDA approved the Monistat 1 Combination Pack for treating vaginal yeast infections. It declared the product safe and it works well when used as instructed in the label. 

The FDA had also instructed that the final printed labels must match the approved samples, or the product may be considered misbranded. The company had submitted the final labels electronically and followed the rules.

According to the Monistat website, the combination pack may lead to mild increase in vaginal burning, itching, or irritation when the applicator containing the cream is inserted. Abdominal cramping has also been reported. This side effect may occur in some cases but not to all those who use it.

So claiming Monistat as unsafe to all will be misleading, as it has been evaluated and approved. 

Apart from this, the product uses various other additives like Benzoic Acid, BHA, Pegliol 7 Stearate. Let’s look at the safety of each of the ingredients. 

Benzoic Acid: Benzoic acid is a natural ingredient occurring in many foodstuffs and in plant extracts. Benzoic acid, its salts and esters are used as preservatives in cosmetic products, with a maximum concentration of 0.5 %. Benzoic acid and sodium benzoate are on the FDA list of substances that are generally recognized as safe (GRAS). Both have been approved to be used as antimicrobial agents, flavouring agents and as adjuvants with a current maximum level of 0.1% in food.

The EFSA reviewed the safety of benzoic acid and its salts (sodium, potassium, and calcium benzoates) as food additives. These substances are quickly absorbed by the body and have low toxicity. Studies showed they are not harmful to genes or cancer-causing, and calcium benzoate is considered similar to the other salts. A study in rats found no harmful effects at a dose of 500 mg/kg per day, and an acceptable daily intake (ADI) of 5 mg/kg was set for humans.

Benzoic acid (E210) has been approved to be used as a preservative by Food Standard Agency UK. 

BHA and Pegliol 7 Stearate: We looked for the list of ingredients in Monistat, and found that BHA and Pegliol 7 Stearate are not in both Medical and Non-Medical ingredient list. Pegliol 7 Stearate is an ingredient in Monistat-Derm, which has different uses and purpose. You can check the list of ingredients here.

Purified Water: Purified water is a standard ingredient in many over-the-counter medications, including Monistat products. It’s used as a base for the cream, helping to dissolve the active ingredient (miconazole nitrate) and other inactive ingredients, allowing them to be properly distributed and applied. It has been approved by the FDA. 

Conclusion: 

Fact Crescendo found the claim to be misleading. Monistat is safe to use and has been approved by the FDA. All the other ingredients in the product have also been approved as safe when used under prescribed limits and good manufacturing practices.