Vaporex

Approved Indications:

• Musculoskeletal Pain Relief: For the topical symptomatic relief of muscle aches, joint pain, strains, sprains, bruises, arthritis, and backache.
• Minor Skin Irritations: Used in conditions like itchiness, insect bites, and local skin irritation due to its counter-irritant and anti-inflammatory properties.
• Chest Congestion Relief: As part of vapor rubs or balms for cough, cold, and nasal congestion, aiding in respiratory comfort.
• Neuralgia: Temporary relief of pain associated with nerve irritation, such as sciatica or post-herpetic neuralgia.

Clinically Accepted Off-label Uses:

• Tension Headache (Topical Application): When applied to the temples or forehead.
• Sinus Pressure Relief: Through topical inhalation or application on the chest.

Adults and Children Over 12 Years:

• Topical Application: Apply a thin layer to the affected area 3 to 4 times daily.
• Massage gently into the skin until fully absorbed.
• Avoid application on broken skin or near eyes, mucous membranes, or genital areas.

Children 2–12 Years:

• Use with caution, preferably under medical supervision.
• Apply no more than 3 times daily.

Children Under 2 Years:

• Contraindicated due to risk of respiratory distress (especially from camphor and menthol).

Inhalational Use (when formulated as vapor rub):

• Rub gently on chest/throat or add a small quantity to hot water for steam inhalation (in adults).

Special Populations:

• Elderly: No specific dose adjustment; monitor for skin sensitivity.
• Hepatic/Renal Impairment: Not systemically absorbed in significant amounts; no dose adjustment necessary, but avoid excessive use.

Each component acts synergistically to provide analgesic, anti-inflammatory, and counterirritant effects. Camphor and Menthol activate TRPM8 and TRPV1 receptors, producing a cooling and then warming sensation that diverts pain signals via a process called counter-irritation. Clove Oil contains eugenol, a natural anesthetic and anti-inflammatory that blocks nerve conduction and reduces local inflammation. Eucalyptus Oil contributes decongestant and anti-inflammatory effects, while Turpentine Oil enhances blood circulation and promotes warmth, helping relieve deep muscular pain.

This combination is topically applied, with minimal systemic absorption when used as directed.

• Absorption: Slight percutaneous absorption; menthol and camphor may penetrate intact skin in small amounts.
• Distribution: Localized to the site of application; not systemically distributed in significant amounts.
• Metabolism: Any absorbed portion of camphor and menthol is metabolized in the liver, primarily via CYP450 enzymes.
• Excretion: Metabolites are excreted via urine.
• Onset of Action: Begins within 5–15 minutes after application.
• Duration of Action: Typically 2–6 hours, depending on the severity of symptoms.

• Pregnancy: Use with caution. While topical application is generally safe in limited areas, camphor and menthol are contraindicated in high doses due to potential teratogenic or fetotoxic effects. Avoid use in the first trimester and during late pregnancy.
• Lactation: Safety is not well established. Avoid application on or near the breast area to prevent infant exposure. Small topical use elsewhere on the body may be acceptable if infant contact is avoided.
• General Advice: Consult a physician before use during pregnancy or lactation.

• Primary Class: Topical Analgesic and Counterirritant
• Subclass: Natural Oil-Based Musculoskeletal Pain Relievers

• Hypersensitivity to camphor, menthol, clove oil, eucalyptus oil, turpentine oil, or any excipients
• Broken, damaged, or irritated skin
• Children under 2 years of age (risk of respiratory depression from camphor)
• Application to mucous membranes or near the eyes
• History of seizures (camphor can lower seizure threshold in high doses)

• Use only externally. Ingestion can be fatal, especially in children.
• Avoid use on large areas of the body or for prolonged periods.
• Discontinue immediately if burning, rash, or irritation occurs.
• Do not apply heat pads or bandages over the application site—may enhance absorption and cause burns.
• Monitor children and elderly for adverse skin reactions or systemic toxicity.
• Flammable—keep away from open flame or heat sources.

Common (Local):

• Skin redness
• Mild burning or tingling
• Dryness or peeling

Less Common:

• Allergic contact dermatitis
• Local rash or itching

Rare but Serious:

• Seizures (due to camphor toxicity, especially if ingested)
• Breathing difficulty in infants (menthol/camphor vapors)

Severity: Mostly mild and self-limited. Serious effects typically linked to misuse or overdose.

• No major systemic drug-drug interactions due to minimal absorption.
• Avoid use with other topical analgesics (e.g., methyl salicylate) to prevent additive irritation.
• Menthol and camphor may interact if combined with topical corticosteroids—may enhance systemic absorption.
• Avoid use with heat therapies or occlusive dressings due to risk of skin damage.

• Pediatric Safety Warnings reinforced globally due to camphor-induced seizures and menthol toxicity—products now carry stricter labeling for use in children.
• FDA and EMA emphasize correct labeling and child-resistant packaging for all products containing camphor and essential oils.
• Newer formulations with reduced camphor concentration are being promoted for safer use in younger populations.

• Store at: 20°C to 25°C (68°F to 77°F)
• Keep in a tightly closed container away from direct sunlight and moisture
• Do not refrigerate or freeze
• Keep away from open flame or sources of heat (flammable)
• Keep out of reach of children
• Avoid contamination: use clean, dry hands for application or use provided applicator if available