Otc - Active Ingredient
Lidocaine 5% w/w
Lidocaine 5% Cream
FDA Label NDC 24689-124
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apnar Pharma Lp for the product Lidocaine 5% (NDC 24689-124). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - ask doctor, otc - keep out of reach of children, directions, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Local Anesthetic
Uses Temporarily relieves pain and itching due to anorectal disorders
Warnings
When using this product
- Avoid contact with eyes
- Do not exceed recommended dosage unless directed by a doctor
Otc - Ask Doctor
- Rectal bleeding occurs
- Condition worsens or does not improve within 7 days
- Allergic reaction occurs
- Redness, irritation, swelling, pain or other symptoms begin or increase
- Symptoms clear up and return within a few days
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
- Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
- Children under 12 years of age: Consult a doctor
Other Safety Information
Store at room temperature 20-25°C (68-77°F); Excursions permitted 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Inactive Ingredient
Benzyl Alcohol, Carbopol 940 (Carbomer 940), Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate (Alpha Tocophferol Acetate)
Dosage
50 miligrams/gram per application
Usage
Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
Children under 12 years of age: Consult a doctor
Package Label.Principal Display Panel
NDC 24689-124-01
Lidocaine 5% Anorectal Cream
Apnar Pharma LP
Net.Wt 30 grams
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