Elixirlidofast Drug Facts

Elixirlidofast Drug Facts
SPL v1
SPL
SPL Set ID 45de9dfa-6c89-1eae-e063-6294a90a4dac
Route
TOPICAL
Published
Effective Date 2025-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (150 mg) Phenylephrine (2.5 mg) Glycerin (144 mg) Lidocaine (50 mg)
Inactive Ingredients
Butylated Hydroxyanisole Carboxymethylcellulose Sodium, Unspecified Cetyl Alcohol Citric Acid Monohydrate Dexpanthenol Edetate Disodium Glyceryl Monostearate Methylparaben Mineral Oil Laureth-23 Steareth-2 Steareth-20 Propyl Gallate Propylene Glycol Propylparaben Water Sodium Benzoate Stearyl Alcohol Tocopherol .alpha.-tocopherol Acetate Xanthan Gum Aloe Vera Leaf Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Glycerin 14.4% Lidocaine 5% Phenylephrine HCl 0.25% White petrolatum 15%

Purpose

Protectant Local anesthetic Vasoconstrictor Protectant


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and 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
Purpose

Protectant Local anesthetic Vasoconstrictor Protectant

Dosage and 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
Description

Glycerin 14.4% Lidocaine 5% Phenylephrine HCl 0.25% White petrolatum 15%

Section 44425-7

Other information

store at 20-25°C (68-77°F)

Section 50565-1

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

Section 50566-9

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
Section 50567-7

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
Section 50568-5

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

Section 50569-3

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

Section 51727-6

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.

Section 53414-9

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

Purposes

Protectant

Local anesthetic

Vasoconstrictor

Protectant

Active Ingredients

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

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


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

store at 20-25°C (68-77°F)

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

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.

Section 53414-9 (53414-9)

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

Purposes

Protectant

Local anesthetic

Vasoconstrictor

Protectant

Active Ingredients

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

Principal Display Panel (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


Advanced Ingredient Data


Raw Label Data

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