Doctor Butler Hemorrhoid And Fissure Ointment
FDA Label NDC 70942-517

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Beyond Health, Pa for the product Doctor Butler Hemorrhoid And Fissure (NDC 70942-517). 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 otc - active ingredient, otc - purpose, uses, warnings, pregnancy, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Glycerin 37.5%, Lanolin 12.5%, Lidocaine 4%, Zinc Oxide 5%

Otc - Purpose

Anorectal (Hemorrhoidal)

Uses

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Warnings

For external and/or intrarectal use only.

When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Ask a doctor before use if you have allergies to any of the components of this product.

Stop use and ask a doctor if condition worsens or does not improve within seven days or bleeding occurs.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • Children under 12 years of age consult your pediatrician.
  • Adults: Apply to the affected area up to 3 times daily.
  • Clean affected area with mild soap and warm water, rinse thoroughly, and gently dry (patting or blotting) with tissue or soft cloth before use.
  • The ointment can be applied using a gloved finger or finger cot.
  • To use finger cots: roll one finger cot over finger. Gently squeeze ointment onto finger cot. Smooth a layer of the ointment over affected area or into anus.

Inactive Ingredient

Aesculus Hippocastanum (Horse Chestnut) Extract

Algae Extract

Argania Spinosa Kernel Oil

Benzyl Alcohol

Calendula Officinalis Flower Extract

Camellia Sinensis Leaf Extract

Cananga Odorata Flower Oil

Canola Oil

Caprylhydroxamic Acid

Caprylic/Capric Triglyceride

Centella Asiatica Extract

Chamomilla Recutita (Matricaria) Flower Extract

Cocos Nucifera (Coconut) Oil

Curcuma Longa (Turmeric) Root Extract

Euphorbia Cerifera (Candelilla) Wax

Glyceryl Caprylate

Helianthus Annuus (Sunflower) Seed Oil

Helianthus Annuus (Sunflower) Seed Wax

Hydrocortisone

Lavandula Angustifolia (Lavender) Oil

Linum Usitatissimum (Linseed) Seed Oil

Lysine HCl

Macadamia Ternifolia Seed Oil

Olea Europaea (Olive) Fruit Oil

Panax Ginseng Root Extract

Persea Gratissima (Avocado) Oil

Pogostemon Cablin Oil

Polyhydroxystearic Acid

Punica Granatum Fruit Extract

Ricinus Communis (Castor) Seed Oil

Rosa Canina Seed Oil

Sodium Hyaluronate

Tocopheryl Acetate

Triethoxycaprylylsilane

Viburnum Opulus Bark Extract

Water

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