Active Ingredient:
Lidocaine 5% w/w
Anecream 5 Cream
FDA Label NDC 24357-702
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Focus Health Group for the product Anecream 5 (NDC 24357-702). 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 active ingredient:, purpose, uses, warnings, when using this product, stop and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Stop And Ask A Doctor If
- 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
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 of blotting with toilet tissue or soft cloth before applying.
- Adults and children 12 years and older: Apply to the affected area up to 6 times a day.
- Children under 12 years of age: Consult a doctor.
Other Information
Store at USP controlled room temperature 20-25C (66-77F).
Inactive Ingredients
benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.
Anecream5 15G Tube Carton
AC 5art 15gm.jpg
The product package shown above represents a sample of that currently in use. Additional packaging may also be available.
Anecream5 Anorectal Cream
Net. Wt. 15g
Distributed by: Focus Health Group
Knoxville, TN 37919
Anecream5 15g Tube Carton
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