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How much camphor is in Campho-Phenique? Understanding the Active Ingredients

3 min read

Since 1983, the U.S. Food and Drug Administration (FDA) has set a limit of 11% on the amount of camphor allowed in over-the-counter medical products due to potential poisoning risks. Campho-Phenique, a long-standing first aid antiseptic, adheres to these regulations by containing a precise amount of the active ingredient, camphor. This article will delve into the specific concentration found in Campho-Phenique's various forms and explain its pharmacological role.

Quick Summary

Campho-Phenique contains 10.8% camphor and 4.7% phenol in both its liquid and gel formulations. These active ingredients provide pain relief and antiseptic properties for minor cuts, scrapes, and skin irritations. The concentration complies with FDA limits for over-the-counter products, and proper, external use is essential for safety.

Key Points

  • Consistent Concentration: All standard Campho-Phenique liquid and gel products contain 10.8% camphor.

  • FDA Regulation: The 10.8% camphor level is purposefully set below the FDA's 11% maximum limit for topical OTC products to ensure safety.

  • Dual Action: Camphor acts as a topical analgesic to relieve pain and itching, while phenol provides antiseptic properties to prevent infection.

  • Formulation Differences: While the active ingredient concentration is the same, the liquid and gel formulations differ in their inactive ingredients, affecting consistency and absorption.

  • External Use Only: Campho-Phenique is for external use only and is highly toxic if swallowed, emphasizing the need for proper storage away from children.

  • Risk of Burns: Camphor-containing products should never be heated or microwaved, as this can cause flammable vapors and severe burns.

In This Article

The Active Ingredients of Campho-Phenique

Campho-Phenique is a well-known over-the-counter (OTC) medication used for its pain-relieving and antiseptic properties. The efficacy of the product stems from its two key active ingredients: camphor and phenol. For both the liquid and gel versions of the standard Campho-Phenique formulations, the concentration of active ingredients is consistently maintained to deliver reliable results.

The ingredient list, as found on the product's packaging and confirmed by the FDA's DailyMed database, specifies the concentrations:

  • Camphor: 10.8%
  • Phenol: 4.7%

This combination, known as 'Camphorated Phenol,' works synergistically. The camphor provides an initial cooling, numbing sensation, while the phenol contributes its anesthetic and germ-killing properties. It's crucial to note that the total amount of camphor is intentionally kept below the FDA's 11% limit for safety.

Formulations: Liquid vs. Gel

Campho-Phenique is available in two primary forms: a liquid and a gel. A common question from consumers is whether the concentration of active ingredients differs between these two formulations. The answer is no; both the liquid and gel products contain the same 10.8% camphor and 4.7% phenol. The primary difference lies in the inactive ingredients, which determine the product's consistency and absorption rate.

Comparison of Campho-Phenique Formulations

Feature Antiseptic Liquid Antiseptic Gel Cold Sore Treatment Gel
Camphor Concentration 10.8% 10.8% 10.8%
Phenol Concentration 4.7% 4.7% 4.7%
Consistency Fast-absorbing liquid Thick gel Targeted, thick gel
Inactive Ingredients Light mineral oil, aloe barbadensis leaf extract, eucalyptus oil Light mineral oil, colloidal silicon dioxide, aloe barbadensis leaf extract, glycerin, eucalyptus oil Light mineral oil, colloidal silicon dioxide, aloe barbadensis leaf extract, glycerin, eucalyptus oil
Primary Use Cases General first aid for minor cuts, scrapes, sunburn, and insect bites General first aid for minor cuts, scrapes, and insect bites Specifically formulated for cold sores and fever blisters

The Pharmacological Role of Camphor

Camphor is a volatile, crystalline substance derived from the wood of the camphor tree. In topical medications like Campho-Phenique, it serves a dual purpose. First, it acts as a topical analgesic, creating a cooling sensation that distracts from and temporarily relieves pain and itching. Second, camphor possesses mild antiseptic properties, which contribute to preventing infection in minor skin injuries. The concentration of 10.8% is carefully chosen to provide these benefits without exceeding the FDA-mandated safety threshold.

Safety and FDA Regulations

The FDA's decision to cap the concentration of camphor at 11% was a direct response to a history of camphor poisoning cases, particularly in children. Camphor can be toxic if ingested, even in small amounts, and can cause serious adverse effects. The regulations ensure that OTC products contain a safe, effective concentration for external use, while highlighting the importance of proper storage and usage.

Key safety precautions when using Campho-Phenique include:

  • For external use only: The product should never be ingested. Ingestion requires immediate medical attention.
  • Avoid broken or large areas of skin: Applying camphor to broken or damaged skin can lead to increased absorption and potential toxicity.
  • Keep away from children: All camphor-containing products should be stored out of the reach of children to prevent accidental ingestion.
  • Do not heat: Heating camphor-containing products can create flammable vapors and cause burns.

For more detailed information, the official product labeling submitted to the FDA's DailyMed database provides comprehensive details on ingredients and usage.(https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=106c0bb2-f2e2-4255-867d-d09ff6a5a2e6)

Conclusion

In summary, Campho-Phenique consistently contains 10.8% camphor in its active ingredient complex, camphorated phenol. This concentration, alongside 4.7% phenol, is formulated to provide effective pain relief and antiseptic action for various minor skin ailments. The key takeaway is that whether you choose the liquid or gel version, the amount of camphor is identical and adheres to strict FDA safety guidelines. Following all usage and storage warnings is crucial to ensure the medication is used safely and effectively.

Frequently Asked Questions

No, both the liquid and gel versions of Campho-Phenique's standard formula contain the same active ingredient percentages: 10.8% camphor and 4.7% phenol.

Yes, 10.8% is considered safe and effective for external, topical use. It is below the 11% limit set by the FDA for camphor in over-the-counter products.

Camphor is used as a topical analgesic and mild antiseptic. It provides a cooling and numbing sensation that temporarily relieves pain and itching.

The other active ingredient is phenol, at a concentration of 4.7%. It acts as an anesthetic and antiseptic.

Ingesting Campho-Phenique can be toxic and is extremely dangerous. If swallowed, you should immediately contact a Poison Control Center or seek medical help.

It is not recommended to use Campho-Phenique on large areas of broken or damaged skin, as this can increase absorption and risk of toxicity.

Yes, Campho-Phenique falls under the OTC monograph drug category and is regulated by the FDA. Its active ingredients and concentrations are within the approved ranges for first aid antiseptics.

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.