MENTHOL + METHYL SALICYLATE +

CAMPHOR
ADALGIA • Children suffering from flu, chickenpox, or fever should avoid using this product
because salicylates may induce Reyes Syndrome.
Analgesic Ointment
Pregnancy and Lactation
Product Description
Safety for use in pregnancy has not been established; therefore the potential benefit
Off-white cream with a tinge of blue and characteristic smell.
of the product should be weighed against the possible risks to the mother and child.
Do not use if pregnant or breastfeeding.
Formulation
Each 5mL (1 teaspoon) contains:
Interactions with Other Medicaments
Methyl salicylate .....................................................................% v/w
This product contains methyl salicylate and when applied or rubbed on to the skin,
% w/w Menthol .................................................................% v/w
can be absorbed through the skin into the blood. For patients taking warfarin,
% w/w Camphor …………………………………………....% v/w or % w/w
excessive application on to the skin for muscle or joints pains may increase the
chances of bleeding.
Pharmacodynamics/ Pharmacokinetics
Pharmacodynamics
Adverse Drug Reactions
Camphor
In addition to accidental ingestion of preparations containing camphor, poisoning has
Camphor is a stimulant, rubefacient, antipruritic and feebly antiseptic. When in
also occurred after giving camphorated oil(camphor liniment) to children in mistake
combination with other ingredient like menthol, methyl salicylate, it becomes ideal
for castor oil. The symptoms include nausea, vomiting, apigastric pain, headache,
for neuralgia and other painful areas.
dizziness, oropharyngeal burning, delirium, muscle twitching, epileptiform
Menthol
convulsions, depression of the CNS, and coma. Breathing is difficult and the breath
Menthol dilates the blood vessels causing a sensation of coldness, followed by an
has a characteristic odor; anuria may occur. Death from respiratory failure or status
analgesic effect. Menthol also acts as a penetration enhancer, increasing the
epileptic may occur; fatalities in children have been recorded from 1 g. There have
penetration of drugs when applied on the skin, to give a faster onset of action.
been reports of instant collapse in infants following the local application of camphor
Methyl salicylate
to their nostrils.
Methyl salicylate is a salicylic acid derivative.
Salicylates inhibit cyclooxygenase, thereby reducing the formation of
Overdose and Treatment
prostaglandins, and cause platelet dysfunction
Supportive care, including anticonvulsant therapy, is the main stay of the treatment of
Methyl salicylate is used topically as a counter-irritant. Upon application, it is
camphor intoxication. Gastric lavage may be considered if the patient presents within
absorbed through the skin and is applied for the relief of pain in rheumatic
1 hour of ingestion; any convulsions must be controlled first. Activated charcoal may
conditions and painful muscle or joints.
be given orally. Haemodialysis with a lipid dialysate or haemoperfusion have been
Pharmacokinetics
tried but are of doubtful value.
Camphor
Camphor is readily absorbed from all administration sites. Camphor is well
Storage Conditions
absorbed after dermal exposure.
Store under normal storage conditions. Store away from Children.
It is hydroxylated in the liver to yield hydroxycamphor metabolites which are then
conjugated with glucuronic acid and excreted in the urine.
Caution
• Discontinue use if excessive irritation of the skin develops. Avoid getting
Indications
into eyes or on mucous membranes.
For the temporary relief of minor aches and pains of muscles and joints associated
• If the conditions worsens, or if the symptoms persists for more than 7
with simple backache, arthritis, strains, bruises and sprains, etc.
days or clears up and occurs again within a few days, discontinue use
of this product and consult a doctor.
Dosage and Mode of Administration
• Do not apply to wounds or damaged skin. Do not bandage tightly.
Adults and children 12 years of age or older: Rub this soothing cream on the
affected area not more that 3 to 4 times daily.
Dosage Forms and Packaging Available
Children under the age of 12: Do not use, consult a doctor.
ADR Reporting Statement
Contraindications
For suspected adverse drug reactions report to FDA:
It should not be included in products intended of the treatment of hepatic and
www.fda.gov.ph
biliary disorders, gallstones, colic, renal disorders, urinary-tract infections, or
ureteral stones. Internal use is discouraged because of its toxicity. It should not
be applied to abraded, irritated skin.

Precautions AdCura Laboratories

Camphor should not be applied to the nostrils of the infants even in small 24 Floor Ayala Life FGU Center
th

quantities, as this may cause immediate collapse. 6811 Ayala Ave Makati, Metro Manila

Warnings
• For external use only. DR No.: 18-03 Manufacturing Date: April 2018
• Can cause convulsions. Batch No.: K-04042018-08 Expiration Date: April 2020
• Topical analgesic preparations containing methyl salicylate should be used Lot No.: K-04042018-0804
with caution in patients at increased risk of developing salicylate adverse
effects.