Cold And Hot
FDA Label NDC 59779-269

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Cold And Hot (NDC 59779-269). 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, purpose, uses, warnings, when using this product, ask a doctor of pharmacist before use if you have:, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 7.60%
Methyl Salicylate 29.00%


Purpose

Vasoconstrictor

Astringent

Uses

Temporarily shrinks hemorrhoidal tissue. Temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders. Ais in protecting irritated anorectal areas.

Warnings

For external use only.

When Using This Product

avoids spraying in eyes. Contents under pressure. Do not puncture or incinerate. DO not store at temperatures above 120F.

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

Ask A Doctor Of Pharmacist Before Use If You Have:

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

    • Ask a doctor or pharmacist before use if

    • you are presently taking a prescription drug for high blood pressure or depression.

Stop Use And Ask A Doctor If

  • bleeding occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • needed for longer than 1 week

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Spray rectal area until thoroughly moist. Wipe off excess with tissue. Gently dry by patting or blotting with a tissue or a soft cloth. Apply 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: Consult a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Benzophenone-4, Disodium EDTA, Hydroxyethylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Sodium Citrate, Tocopheryl Acetate, Water.

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