Camphor and phenol are combined in a topical liquid for the temporary relief of minor pain and pruritus associated with insect bites, scrapes, minor burns (including sunburn), minor skin abrasions, and other skin irritations. The topical gel is marketed for the temporary relief of pain and discomfort associated with herpes labialis (i.e., cold sores or fever blisters). Camphor suppresses cutaneous receptors when used in concentrations of 0.1-3%. Higher concentrations (e.g., > 3%) stimulate cutaneous receptors and act as a counterirritant. Phenol is considered a safe and effective topical oral analgesic/anesthetic when used alone in concentrations of 0.5-1.5%, although higher concentrations have also been considered safe and effective when used in combination with camphor. Neither camphor nor phenol has been accepted as safe and effective for relief of pain associated with aphthous ulcers (i.e., canker sores), as these agents may cause tissue irritation and damage, or systemic toxicity when used for this purpose.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
Other Topical Formulations
-Cleanse the affected area and apply externally according to instructions on product labeling. Do not bandage. Do not use over large areas of the body.
Instruct patients to discontinue use if skin irritation develops, condition worsens, symptoms persist for more than 7 days or clear up and recur within a few days.
Do not apply camphor; phenol over large areas of the body. Do not cover with a bandage or occlusive dressing.
The safety and efficacy of camphor; phenol has not been established in neonates, infants, or children < 2 years. Although camphor; phenol products are FDA-approved for topical administration in children >= 2 years, because of the risk of toxicity due to camphor exposure in children and the availability of alternative therapies, the American Academy of pediatrics recommends consideration of alternative therapies that do not contain camphor.
A specific FDA pregnancy risk category has not been assigned to camphor; phenol products for topical use. However, expert opinion commonly categorizes these products in FDA pregnancy risk category C due to lack of data.
There is insufficient evidence to determine the safety of topically applied camphor; phenol in a breast-feeding woman. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
For use as first aid to prevent infection and for the temporary relief of minor pain and pruritus associated with insect bites or stings, minor burns (including sunburn), minor skin abrasion, and other skin irritations:
Topical dosage:
Adults, Adolescents, and Children >= 2 years: Apply directly to cleansed, affected area 1-3 times daily. Do not bandage.
Neonates, Infants, and Children < 2 years: Safety and efficacy have not been established.
For first aid to help prevent infection and the temporary relief of pain and pruritus associated with herpes labialis (i.e., cold sores or fever blisters):
Topical dosage:
Adults, Adolescents, and Children >= 2 years: Apply directly to cleansed cold sore or fever blister 1-3 times daily. Do not bandage.
Neonates, Infants, and Children < 2 years: Safety and efficacy have not been established.
Maximum Dosage Limits:
-Adults
No maximum dosage information is available.
-Geriatric
No maximum dosage information is available.
-Adolescents
No maximum dosage information is available.
-Children
>= 2 years: No maximum dosage information is available.
< 2 years: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Camphor; Phenol products.
Mechanism of Action:-Camphor: Camphor acts as a local anesthetic, antipruritic, antiseptic when applied topically.
-Phenol: Phenol acts as a topical nalgesic/anesthetic when used alone in concentrations of 0.5-1.5%, although higher concentrations have also been considered safe and effective when used in combination with camphor.
Camphor; phenol is applied topically to the skin.
-Route-Specific Pharmacokinetics
Topical Route
-Camphor: Camphor is highly lipophilic. It is rapidly absorbed across mucous membranes and has a large volume of distribution. Camphor is oxidized to camphorol, which is then glucuronidated in the liver. Active metabolites are stored in fat deposits and cleared over a prolonged period of time. Camphor is primarily excreted in the urine.