FDA Label for Lidocaine 5%
View Indications, Usage & Precautions
Lidocaine 5% Product Label
The following document was submitted to the FDA by the labeler of this product Apnar Pharma Lp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Lidocaine 5% w/w
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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