Lanolin

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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
Lanolin is a non-petroleum based lubricants that is FDA approved for the treatment of diaper dermatitis and protection of chafed skin or minor skin irritations due to incontinence.   Common adverse reactions include burning, stinging, redness and  irritation.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding FDA-Label Guideline-Supported Use of Lanolin in adult patients.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lanolin in adult patients.

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

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

# Indications
- Helps prevent and treat diaper dermatitis
- Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness.

## Off-Label Use and Dosage (Pediatric)

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

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

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

# Warnings
- For External Use Only
- Avoid contact with eyes
- Do not apply to deep or puncture wounds
- If condition worsens, or does not improve within 7 days, consult a doctor
KEEP OUT OF REACH OF CHILDREN
- If swallowed, get medical help or contact a Poison Control Center right away

# Adverse Reactions

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

## Postmarketing Experience
- There is limited information regarding Postmarketing Experience of Lanolin in the drug label.

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

# Use in Specific Populations

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

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

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

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

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

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

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

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

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

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

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

# Administration and Monitoring

### Administration
- Topical
- Gently cleanse and dry area
- Apply liberally to affected area as needed
- Avoid contact with eyes
- Do not apply to deep or puncture wounds
- If condition worsens, or does not improve within 7 days, consult a doctor

### Monitoring
- There is limited information regarding Monitoring of Lanolin in the drug label.

# IV Compatibility
- There is limited information regarding IV Compatibility of Lanolin in the drug label.

# Overdosage
- There is limited information regarding Chronic Overdose of Lanolin in the drug label.

# Pharmacology
There is limited information regarding Lanolin Pharmacology in the drug label.

## Mechanism of Action
There is limited information regarding Lanolin Mechanism of Action in the drug label.

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

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

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

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

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

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

## Storage
- Store at room temperature 20 deg C to 25 deg C 68 deg F to 77 deg F

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Lanolin in the drug label.

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

# Brand Names
- LANOLIN 

# Look-Alike Drug Names
- A  B

# Drug Shortage Status

# Price