Camphor (synthetic), menthol and methyl salicylate plaster
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
Camphor (synthetic), menthol and methyl salicylate plaster is an external analgesic that is FDA approved for the treatment of simple backache,arthritis,strains,bruises,sprains. Common adverse reactions include seizures, nausea , vomiting, warmth ,headache , confusion ,vertigo, delirium, hallucinations,tremors, contact eczema.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- For the temporary relief of minor aches and pains of muscles and joints due to:
Dosage
- Clean the affected area. Remove the paper film from the plaster.
- Adults: apply one plaster to affected area not more than 3 to 4 times daily
- Children under 12 years of age: do not use, consult your physician refer to the above warnings; use otherwise than as directed may be dangerous
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Camphor (synthetic), menthol and methyl salicylate plaster in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Camphor (synthetic), menthol and methyl salicylate plaster in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
- For the temporary relief of minor aches and pains of muscles and joints due to:
Dosage
- Clean the affected area. Remove the paper film from the plaster.
- Children 12 years of age and older: apply one plaster to affected area not more than 3 to 4 times daily
- Children under 12 years of age: do not use, consult your physician refer to the above warnings; use otherwise than as directed may be dangerous
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Camphor (synthetic), menthol and methyl salicylate plaster in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Camphor (synthetic), menthol and methyl salicylate plaster in pediatric patients.
Contraindications
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Contraindications in the drug label.
Warnings
- For external use only
- Allergy alert: This product contains natural rubber latex which may cause allergic reactions
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Clinical Trials Experience in the drug label.
Postmarketing Experience
- Seizures
- Nausea and vomiting
- warmth
- Headache
- Confusion
- Vertigo
- Delirium
- Hallucinations
- Tremors
- Elevated lactate dehydrogenase
- Elevated aspartate aminotransferase-to-alanine aminotransferase ratio
- Contact eczema
Drug Interactions
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Camphor (synthetic), menthol and methyl salicylate plaster in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Camphor (synthetic), menthol and methyl salicylate plaster in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Camphor (synthetic), menthol and methyl salicylate plaster during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Camphor (synthetic), menthol and methyl salicylate plaster in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Camphor (synthetic), menthol and methyl salicylate plaster in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Camphor (synthetic), menthol and methyl salicylate plaster in geriatric settings.
Gender
There is no FDA guidance on the use of Camphor (synthetic), menthol and methyl salicylate plaster with respect to specific gender populations.
Race
There is no FDA guidance on the use of Camphor (synthetic), menthol and methyl salicylate plaster with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Camphor (synthetic), menthol and methyl salicylate plaster in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Camphor (synthetic), menthol and methyl salicylate plaster in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Camphor (synthetic), menthol and methyl salicylate plaster in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Camphor (synthetic), menthol and methyl salicylate plaster in patients who are immunocompromised.
Administration and Monitoring
Administration
External application
Monitoring
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Camphor (synthetic), menthol and methyl salicylate plaster and IV administrations.
Overdosage
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Mechanism of Action in the drug label.
Structure
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Structure in the drug label.
Pharmacodynamics
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Clinical Studies in the drug label.
How Supplied
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster How Supplied in the drug label.
Storage
- Keep in a tightly closed container
- Store at room temperature 15º to 30º C (59º to 86º F), away from sunlight
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
DO NOT USE
- On irritated or damaged skin
- On wounds
- With a heating pad
- If pregnant or nursing
- Otherwise than as directed
WHEN USING
- Avoid contact with the eyes or mucous membranes
- Do not bandage tightly
STOP USE
- Stop use and ask a doctor if
- Condition worsens
- Symptoms persist for more than 7 days
- Symptoms clear up and occur again within a few days
- Excessive irritation of the skin develops
- Nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
- When using for pain of arthritis:
- Pain persists for more than 10 days
- Redness is present
- In conditions affecting children under 12 years of age
Precautions with Alcohol
Alcohol-Camphor (synthetic), menthol and methyl salicylate plaster interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
701 DIEDA ZHENGTONG YAOGAO MEDICATED PLASTER
Look-Alike Drug Names
There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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