Thera Plus Hemorrhoidal Cream
FDA Label NDC 80684-210

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fourstar Group Usa, Inc. for the product Thera Plus Hemorrhoidal (NDC 80684-210). 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, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Glycerin 14.4%,
Phenylephrine HCl 0.25%
Pramoxine HCl 1%
White petrolatum 15%

Purpose

Protectant
Vasoconstrictor
Local anesthetic
Protectant

Uses

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

Warnings

For external use only.

Ask A Doctor Or Pharmacist Before Use If You Are

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

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

When Using This Product

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

Stop Use And Ask A Doctor If

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • the symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. some people can develop allergic reactions to ingredients in this product.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. 
  • apply externally to the affected area up to 4 times daily, especially at night or in the morning or after each bowel movement.
  • apply externally or in the lower portion of the anal canal only.
  • for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
  • Children under 12 years of age: consult a doctor.

Other Information

  • store at room temperature 68 °- 77° F (20° - 25° C).

Inactive Ingredients

aloe barbadensis leaf juice, carboxymethycellulose sodium, cetyl alcohol, methylparaben, mineral oil, mono-and di-glycerides, propylene glycol, propylparaben, purified water, stearic acid, tween 80, xanthan gum

Questions?

1-800-639-3803Weekdays 9 AM to 4 PM EST

Package Labeling:

Label3 (Label3)

Label3 (Label3)

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