Elixirlidofast Rapid Relief Cream
FDA Label NDC 84546-0006

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 Rapid Relief (NDC 84546-0006). 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 ingredients, purposes, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

Purposes

Protectant

Local anesthetic

Vasoconstrictor

Protectant

Indications & Usage

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful

Warnings

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

Otc - When Using

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Otc - Stop Use

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying this cream.
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor

Storage And Handling

Other information

store at 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients

Aloe vera leaf, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methyl paraben, mineral oil, laureth 23, steareth 2, steareth 20, propyl gallate, propylene glycol, propyl paraben, sodium benzoate, stearyl alcohol, tocopherol, alpha-tocopherol acetate, xanthan gum, purified water.

Principal Display Panel

TO OPEN PUSH DOWN ON CAP WHILE

TURNING COUNTERCLOCKWISE

Elixir

HEMORRHOIDAL CREAM

RAPID RELIEF WITH LIDOCAINE, 5% HIGHEST STRENGTH LIDOCAINE AVAILABLE

RAPID NUMBING RELIEF OF PAIN, LATCHING & BURNING

REDUCES SWELLING & PROVIDES A SOOTHING PROTECTIVE LAYER.

Lidocaine, Phenylephrine HCL, Glycerin, White Petrolatum

4 oz|113g

Child Resistant Packaging

113g-tube.jpg (113g Tube)

113g-tube.jpg (113g Tube)

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