Doctor Butlers Hemorrhoid and Fissure
Doctor Butler's Hemorrhoid and Fissure Cream External Pain Formula
d92f22a7-c0b5-d8b8-e053-2a95a90a2376
HUMAN OTC DRUG LABEL
Sep 30, 2025
Beyond Health, P.A.
DUNS: 026781064
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine 5%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (25)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
1.5oz / 42.5g jar
INDICATIONS & USAGE SECTION
Uses
Helps relieve the local itching and discomfort associated with anorectal disorders or inflammation.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Lidocaine USP 5.0%
OTC - PURPOSE SECTION
Purpose
Analgesic (pain reliever)
WARNINGS SECTION
Warnings
For external use onlyincluding the skin of the anal canal
When using this product
- avoid contact with eyes
- do not exceed recommended dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- allergic reactions to ilgredients in this product
- symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
If pregnant or breast-feeding
ask a health care professional before use
Keep out of reach of children.
If swallowed, seek medical help or contact a Poison Control Cener right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- When practical, cleanse the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
- Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
- Children under 12 years of age: consult a doctor.
SPL UNCLASSIFIED SECTION
Other information
- store at 15º-30º C (59ºto 86º F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
Aesculus Hippocastanum (Horse Chestnut) Extract, Benzyl Alcohol, Calendula Officinalis Flower Extract, Carbomer, Carya Ovata Bark Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Curcuma Longa (Turmeric) Root Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Helichrysum Italicum Extract, Hydrogenated Lecithin, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Panax Ginseng Root Extract, Polysorbate 80, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate, Tocopheryl Acetate, Triethanolamine, Water.