Comfort Candy Hemorrhoidal Gel

Comfort Candy Hemorrhoidal Gel
SPL v1
SPL
SPL Set ID 4951d984-3e86-4eb6-9505-2c506e22fda2
Route
TOPICAL
Published
Effective Date 2025-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Alcohol Allantoin Aloe Vera Leaf Juice Citric Acid Monohydrate Dimethyl Sulfone Edetate Disodium Ethylhexylglycerin Glycerin Phenoxyethanol Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-20
Description

Lidocaine 5.00 % Phenylephrine Hcl 0.25%

Purpose

Anorectal (hemorrhoidal) Anorectal (vasoconstrictor)

Medication Information

Purpose

Anorectal (hemorrhoidal)

Anorectal (vasoconstrictor)

Description

Lidocaine 5.00 % Phenylephrine Hcl 0.25%

Uses
  • For the temporary relief of pain, irritation, or burning.
Do Not
  • exceed the recommended daily dosage unless directed by a doctor. 
  • put this product into the rectum by using your fingers or any mechanical device or applicator. 
  • use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate glad unless directed by a doctor.
Warnings:

For external use only

Drug Facts

Questions?

(435-295-4328)

Directions:

Adults:

  • When practical, cleanse the affected area with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad. 
  • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.
  • Children under 12 years of age: consult a doctor.
Package Labeling:

Active Ingredients

Lidocaine 5.00 %

Phenylephrine Hcl 0.25%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

Alcohol, Allantoin, Aloe Barbadensis Leaf Juice, Citric Acid, Dimethyl Sulfone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Water (Aqua), Xanthan Gum

When Using This Product
  • If the condition worsens or does not improve within 7 days, consult a doctor. 
  • In case of bleeding, consult a doctor promptly.
Stop Use and Ask A Doctor
  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding ,

ask a health professional before use.

Ask A Doctor Or Pharmacist Before Use If You Are
  • presently taking a prescription drug for high blood pressure or depression.

Allergy alert



  • Certain persons can develop allergic reactions to ingredients in this product.

Structured Label Content

Uses
  • For the temporary relief of pain, irritation, or burning.
Do Not (Do not)
  • exceed the recommended daily dosage unless directed by a doctor. 
  • put this product into the rectum by using your fingers or any mechanical device or applicator. 
  • use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate glad unless directed by a doctor.
Purpose

Anorectal (hemorrhoidal)

Anorectal (vasoconstrictor)

Warnings:

For external use only

Drug Facts

Questions?

(435-295-4328)

Directions:

Adults:

  • When practical, cleanse the affected area with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad. 
  • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.
  • Children under 12 years of age: consult a doctor.
Package Labeling:

Active Ingredients

Lidocaine 5.00 %

Phenylephrine Hcl 0.25%

Other Information: (Other information:)
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients: (Inactive ingredients:)

Alcohol, Allantoin, Aloe Barbadensis Leaf Juice, Citric Acid, Dimethyl Sulfone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Water (Aqua), Xanthan Gum

When Using This Product (When using this product)
  • If the condition worsens or does not improve within 7 days, consult a doctor. 
  • In case of bleeding, consult a doctor promptly.
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
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.

If Pregnant Or Breast Feeding , (If pregnant or breast-feeding ,)

ask a health professional before use.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • presently taking a prescription drug for high blood pressure or depression.

Allergy alert



  • Certain persons can develop allergic reactions to ingredients in this product.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:36.816110 · Updated: 2026-03-14T23:09:28.158875