Doctor Butler's Hemorrhoid And Fissure Cream External Pain Formula

Doctor Butler's Hemorrhoid And Fissure Cream External Pain Formula
SPL v6
SPL
SPL Set ID d92f22a7-c0b5-d8b8-e053-2a95a90a2376
Route
TOPICAL
Published
Effective Date 2025-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Melaleuca Alternifolia Leaf Turmeric Hamamelis Virginiana Leaf Carya Ovata Bark Calendula Officinalis Flower Centella Asiatica Triterpenoids Olea Europaea Leaf Benzyl Alcohol Carbomer 940 Polysorbate 80 Cholesterol Hydrogenated Soybean Lecithin Isopropyl Myristate Propylene Glycol Water Trolamine .alpha.-tocopherol Acetate Horse Chestnut Asian Ginseng Lavandula Angustifolia Flower Rosemary Matricaria Chamomilla Helichrysum Italicum Flower Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-01 Until 2025-07-17

Description

Lidocaine USP 5.0%

Purpose

Analgesic (pain reliever)


Medication Information

Purpose

Analgesic (pain reliever)

Description

Lidocaine USP 5.0%

Uses

Helps relieve the local itching and discomfort associated with anorectal disorders or inflammation.

Warnings

For external use only including the skin of the anal canal

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.
1.5oz / 42.5g Jar

Active Ingredient

Lidocaine USP 5.0%

Other Information
  • store at 15º-30º C (59ºto 86º F)
0.75 Oz / 21.3g Tube

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.

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.


Structured Label Content

Uses

Helps relieve the local itching and discomfort associated with anorectal disorders or inflammation.

Purpose

Analgesic (pain reliever)

Warnings

For external use only including the skin of the anal canal

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.
1.5oz / 42.5g Jar (1.5oz / 42.5g jar)

Active Ingredient

Lidocaine USP 5.0%

Other Information (Other information)
  • store at 15º-30º C (59ºto 86º F)
0.75 Oz / 21.3g Tube (0.75 oz / 21.3g tube)

Inactive Ingredients (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.

When Using This Product (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 (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 (If pregnant or breast-feeding)

ask a health care professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, seek medical help or contact a Poison Control Cener right away.


Advanced Ingredient Data


Raw Label Data

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