Camphor (synthetic), menthol and methyl salicylate plaster

Camphor (synthetic), menthol and methyl salicylate plaster
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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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Overview

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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:
  • simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Dosage

• Clean the affected area. Remove the paper film from the plaster.
• Adults and 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 (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)

There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

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

There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Postmarketing Experience in the drug label.

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

There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Administration in the drug label.

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

There is limited information regarding Camphor (synthetic), menthol and methyl salicylate plaster Brand Names in the drug label.

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.