Pramoxine Hydrochloride Anorectal Lotion
FDA Label NDC 58980-522

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharmaceuticals for the product Pramoxine Hydrochloride Anorectal (NDC 58980-522). 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 other, active ingredient, purpose, use, warnings, do not, stop use and ask a physician if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
STRATUS
PHARMACEUTICALS INC
Miami, Florida 33186

Active Ingredient

Pramoxine HCL 1% w/w

Purpose

Local Anesthetic

Use

  • for the temporary relief of itching and discomfort in the perianal area.

Warnings

for external use only.

Do Not

  • exceed the recommended daily dosage unless directed by a Physician.
    • put this product into rectum by using fingers or any applicator.

Stop Use And Ask A Physician If

  • Condition worsens
  • Symptoms do not improve in 7 days
  • Allergic reactions develop to ingredients in this product
  • Symptoms being treated do not improve or subsideor if redness, irritation, swelling, pain, bleeding or other symptoms develop or increase

Otc - Keep Out Of Reach Of Children

Keep this product out of the reach of children. If swallowed, get medical attention or contact a Poison Control Center right away.

Directions

  • Shake well before using.
  • When practical, cleansethe 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.
  • Adults and children 12 years of age and older: apply to affected area up to five times daily.
  • Children under 12 years of age, consult a Physician.

Inactive Ingredients

Carbomer 940, Cetyl Alcohol, Di-isopropyl Adipate, Dimethicone, Glycerin 99.7%, Lanolin Anhydrous, Light Mineral Oil, PEG 40 Stearate, Potassium Sorbate, Purified Water, Sorbic Acid, Stearic Acid, Stearyl Alcohol, Trolamine, Ultimate White Petrolatum.

Questions Or Comments?

Call us at: 1-800-442-7882

Principal Display Panel - 118 Ml Bottle Box

NDC 58980-522-40

ANORECTAL

PRAMOXINE
HYDROCHLORIDE 1%

ANORECTAL

FAST RELIEF FROM ITCH
AND DISCOMFORT

ANORECTAL
(hemorrhoidal)
LOTION

Net 4 fl oz (118 mL)

Principal Display Panel (118 mL Bottle Box)

Principal Display Panel (118 mL Bottle Box)

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