Comfort Candy Hemorrhoidal Gel
FDA Label NDC 85956-624

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bowler Esthetics, Inc for the product Comfort Candy Hemorrhoidal (NDC 85956-624). 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 ingredients, purpose, uses, warnings:, do not, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Lidocaine 5.00 %
Phenylephrine Hcl 0.25%

Purpose

Anorectal (hemorrhoidal)
Anorectal (vasoconstrictor)

Uses

  • For the temporary relief of pain, irritation, or burning.

Warnings:

For external use only

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.

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.

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.

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.

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.

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

Questions?

(435-295-4328)

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