benzalkonium chloride/menthol/petrolatum topical

Action and Spectrum

Drug Interaction

Adverse Reaction

N/A 

Black Box Warning

Black box warning: 

None 

Contraindication / Caution

Contraindications/caution: 

Contraindications: 

None 

Caution: 

• Allergies or Sensitivities: Individuals may be allergic or sensitive to certain ingredients in the combination product. Discontinue use if any signs of an allergic reaction, such as itching,rash,  or swelling, occur. If you have known allergies or sensitivities, consult a healthcare professional before using the product. 
• Avoid Eye Contact: Avoid applying the combination product near or in the eyes, as it may cause irritation or stinging. If accidental eye contact occurs, rinse the eyes thoroughly with water and seek medical attention if irritation persists. 
• Open Wounds or Broken Skin: Do not apply the combination product to open wounds, cuts, or broken skin, as it may cause further irritation or delay the healing process. It is essential to allow the skin to heal before using the product. 
• Avoid Ingestion: The combination product is intended for external use only. It should not be ingested or swallowed. If accidentally swallowed, seek medical attention immediately. 
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, consult a healthcare professional before using the combination product. Some ingredients may have potential risks, and professional guidance can help determine the product’s suitability for your specific situation. 
• Children: When using the combination product on children, follow the recommended age restrictions and usage guidelines specified on the product packaging. 

Pregnancy / Lactation

Pregnancy consideration: C 

Lactation: Excretion of the drug in human breast milk is unknown 

Pregnancy category: 

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology: 

The combination of benzalkonium chloride, menthol, and petrolatum in a topical formulation may provide a synergistic effect, combining the antimicrobial properties of benzalkonium chloride, the cooling and local anesthetic effects of menthol, and the skin protective and moisturizing 

Pharmacokinetics: 

Absorption 

benzalkonium chloride can be absorbed through the skin, but the extent of absorption depends on factors such as concentration, skin integrity, and the specific formulation. Higher concentrations and damaged skin may enhance absorption. menthol can be absorbed through the skin, but the rate and extent of absorption can vary.

Concentration, skin integrity, and the specific formulation can influence absorption. petrolatum forms a protective barrier on the skin’s surface and is not significantly absorbed through intact skin. However, it can enhance the absorption of other substances when applied concurrently. 

Distribution 

Once absorbed, benzalkonium chloride can distribute throughout the body. It may bind to proteins in the blood and tissues. Once absorbed, menthol can distribute to various tissues throughout the body. petrolatum remains primarily on the skin’s surface and does not extensively distribute throughout the body. 

Metabolism 

benzalkonium chloride is not significantly metabolized in the body.menthol is primarily metabolized in the liver by enzymes such as cytochrome P450. It undergoes phase I metabolism, primarily through hydroxylation and glucuronidation. The body does not metabolize petrolatum. 

Elimination and Excretion 

benzalkonium chloride and its metabolites are primarily excreted through the urine. Metabolites of menthol are excreted through the urine.petrolatum is not significantly excreted from the body. 

Adminstartion

Administration: 

• Clean the affected area: Before applying the topical product, gently clean the area with mild soap and water and pat it dry. 
• Apply a thin layer: Use a clean applicator, such as a cotton swab or clean hands, to apply a thin layer of the topical product to the affected area. Follow the instructions provided by the manufacturer regarding the amount to use and the frequency of application. 
• Massage or rub gently: If directed, gently massage or rub the topical product into the skin until it is absorbed. This can help ensure even distribution and better penetration of the product. 
• Wash hands after application: After applying the product, wash your hands thoroughly to avoid spreading the product to unintended areas or accidental ingestion. 
• Follow product-specific instructions: Always read and follow the instructions provided by the manufacturer on the product packaging. Different combination products may have specific administration instructions, such as applying before or after bathing or at specific times of the day. 
• Store as directed: Follow the storage instructions provided by the manufacturer to maintain the product’s effectiveness and stability. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: benzalkonium chloride/menthol/petrolatum topical 

Why do we use benzalkonium chloride/menthol/petrolatum topical? 

The specific uses of a combination product containing benzalkonium chloride, menthol, and petrolatum topical may depend on the formulation and intended purpose.  

• Skin Irritations: The combination product may be used to provide relief from minor skin irritations such as itching, redness, and inflammation caused by insect bites, rashes, or allergies. 
• Dry or Chapped Skin: The combination product can be applied to dry or chapped skin to moisturize and help soothe the skin. It may be used on areas such as elbows, knees, and heels prone to dryness. 
• Minor Cuts or Scrapes: The combination product may be used as an antiseptic for cleansing and protecting minor cuts, scrapes, or burns. It can help prevent infection and promote healing. 
• Sunburn Relief: The combination product may be applied to sunburned skin to provide a cooling sensation, relieve discomfort, and help moisturize the affected area. 
• Lip Care: The combination product may soothe and moisturize dry, chapped lips.