Elixirlidofast Cream
FDA Label NDC 84546-0010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elixir Healthcare Usa, Llc. for the product Elixirlidofast (NDC 84546-0010). 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 drug facts:, active ingredient (in each gram), purpose, uses, warnings:, when using this product,, dosage, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Gram)
Lidocaine 5% w/w
Purpose
Anorectal (hemorrhoidal) cream
Uses
Helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorder.
Warnings:
• For external use only
When Using This Product,
• Avoid contact with eyes.
• Do not exceed recommended dosage unless direct by a doctor.
• Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Dosage
• If pregnant or breastfeeding: ask a health professional before use.
Stop Use And Ask A Doctor If
• rectal bleeding occurs
• Condition worsens or does not improve within 7 days
• Allergic reaction occurs to ingredients in this product.
• Symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
• Symptoms clear up and return within few days.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
apply liberally as often as necessary
For diaper rash:
• change wet or soiled diapers promptly
• cleanse the diaper area and allow to dry
• apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged
Inactive Ingredients
Benzyl alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Trolamine, Vitamin E Acetate, Purified Water
Other Information
• Store at temperature below 30°C.
• Do not freeze. Protect from direct sunlight.
Packaging Label For The Tube 30G
Elixir
LINDOCAINE CREAM 5%
Topical Cream
WORK FASTER LASTS LONGER
Image Description (30g Tube Label)
Packaging Label For The Tube 60G
Elixir
LINDOCAINE CREAM 5%
Topical Anorectal Cream
WORK FASTER LASTS LONGER
Pian Relife For Hemorrhoids & other
Anorectal Disorders
Relieves Pian, Relieves Itching, Relieves Burining
1 Tube Net WT.2 oz (60g)
Image Description (60g Tube)
Packaging Label For The Jar 142G
Elixir
STONGEST
NON-PRESCIPTION
LINDOCIANE
ANORECTAL (HEMORRHOIDAL) CREAM
5% LINDOCAINE, WORKS FASTER LASTS LONGER 5oz VALUE SIZE!
Child Resistant Packaging
5oz| 142g
Image Description (142g Jar)
Packaging Label For The Jar 156G
Elizir LdioEase Numbing Cream
Lindocaine Anorectal Cream 5% w/w
5% LIDOCAINE
WORK FASTER LASTS LONGER
5.5oz|156g
Image Description (156g Jar)
* Please review the disclaimer below.
