Salicylic acid

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# Overview
Salicylic acid is an anti acne agent that is FDA approved for the treatment of acne, for relief of itching, irritation, redness and scaling assoicated with psoriasis, eczema and seborrheic dermatitis.   Common adverse reactions include hypersensitivity reaction, salicylate toxicity.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- FOR THE TREATMENT OF ACNE
- HELPS KEEP SKIN CLEAR OF NEW ACNE BLEMISHES
- For relief of itching, irritation, redness and scaling assoicated with psoriasis, eczema and seborrheic dermatitis.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
- Acne vulgaris
- Apply TOPICALLY in concentrations of 0.5% to 10%
- Disorder of skin, Hyperkeratotic: gel, apply TOPICALLY to the affected area and occlude the area at night.
- Disorder of skin, Hyperkeratotic
- shampoo, wet hair and apply TOPICALLY to the scalp, work into a lather and rinse; repeat the treatment as needed until the condition clears 
- Psoriasis
- Apply TOPICALLY in concentrations of 3% to 6%
- Removal of wart
- Apply TOPICALLY once or twice daily in concentrations of 5% to 40% for up to 12 weeks

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Salicylic acid in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-labeled indications and dosage information of Salicylic acid in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Salicylic acid in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Salicylic acid in pediatric patients.

# Contraindications
There is limited information regarding Salicylic acid Contraindications in the drug label.

# Warnings
- For external use only.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use without consulting a doctor if the condition appears over a large portion of hte body.
- If condition worsens, or does not improve after using as directed, consult physician.
- Do not use for prolonged periods without consulting a doctor.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Salicylic acid in the drug label.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Salicylic acid in the drug label.

# Drug Interactions
There is limited information regarding Salicylic acid Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- Pregnancy Category
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Salicylic acid in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Salicylic acid during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Salicylic acid with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Salicylic acid with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Salicylic acid with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Salicylic acid with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Salicylic acid with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Salicylic acid in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Salicylic acid in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Salicylic acid in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Salicylic acid in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Topical

### Monitoring
There is limited information regarding Monitoring of Salicylic acid in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Salicylic acid in the drug label.

# Overdosage
There is limited information regarding Chronic Overdose of Salicylic acid in the drug label.

# Pharmacology

## Mechanism of Action
- Salicylic acid has been shown to work through several different pathways. It produces its anti-inflammatory effects via suppressing the activity of cyclooxygenase (COX), an enzyme that is responsible for the production of pro-inflammatory mediators such as the prostaglandins.
- It does this not by direct inhibition of COX like most other non-steroidal anti-inflammatory drugs (NSAIDs) but instead by suppression of the expression of the enzyme (via a yet-unelucidated mechanism).
- Salicylic acid has also been shown to activate adenosine monophosphate-activated protein kinase (AMPK), and it is thought that this action may play a role in the anticancer effects of the compound and its prodrugs aspirin and salsalate. In addition, the antidiabetic effects of salicylic acid are likely mediated by AMPK activation primarily through allosteric conformational change that increases levels of phosphorylation.
- Salicylic acid also uncouples oxidative phosphorylation, which leads to increased ADP:ATP and AMP:ATP ratios in the cell. As a consequence, salicylic acid may alter AMPK activity and subsequently exert its anti-diabetic properties through altered energy status of the cell. Even in AMPK knock-out mice, however, there is an anti-diabetic effect, demonstrating that there is at least one additional, yet-unidentified action of the compound.

## Structure
There is limited information regarding Salicylic acid Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Salicylic acid in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Salicylic acid in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Salicylic acid in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Salicylic acid in the drug label.

# How Supplied
There is limited information regarding Salicylic acid How Supplied in the drug label.

## Storage
There is limited information regarding Salicylic acid Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
- Wash affected areas well with soap and water. Pat dry. Apply cream to affected area one to four times per day, or as directed by physician.

# Precautions with Alcohol
- Alcohol-Salicylic acid interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- ALA-SEPTIC

# Look-Alike Drug Names
There is limited information regarding Salicylic acid Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price