DR. BUTLER HEMORRHOID TREATMENT- phenylephrine hydrochloride 0.25%, witch hazel 50% spray

Dr. Butler Hemorrhoid Treatment by

Drug Labeling and Warnings

Dr. Butler Hemorrhoid Treatment by is a Otc medication manufactured, distributed, or labeled by Beyond Health P.A., Derma Care Research Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Phenylephrine HCl 0.25%, Witch Hazel 50%

PURPOSE

Vasoconstrictor, Astringent

INDICATIONS & USAGE

Temporarily reduces swelling associated with hemorrhoidal tissue. Temporary relief of anorectal itching and discomfort associated with hemorrhoids and other anorectal disorders.

WARNINGS

For external use only.

When using this product avoid spraying in eyes, contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F, do not exceed recommended daily dosage unless directed by a doctor, do not put this product in the rectum by using fingers or any mechanical device or applicator.

Ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland, presently taking a prescription for high blood pressure or depression.

Stop use and ask a doctor if bleeding occurs, the condition worsens, symptoms last more than 7 days or clear up and occur again within a few days, needed for longer than 1 week.

Ask a healthcare or professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Adults: when practical, cleanse the affected area with mild soap and warm water and pat dry. Spray the rectal area until thoroughly moist. Wipe off excess with a tissue, gently dry by patting or blotting with a tissue or a soft cloth, apply to the affected area up to 4 times daily especially at night in the morning or after each bowel movement. For children under 12 years of age, consult a doctor.

INACTIVE INGREDIENT

Alcohol, Aloe Barbadensis Leaf Extract, Benzophenone-4, Benzyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Hydroxyethylcellulose, Polysorbate 80, Propylene Glycol, Propylparaben, Sodium Citrate, Tocopherol, Tocopheryl Acetate, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. BUTLER HEMORRHOID TREATMENT 
phenylephrine hydrochloride 0.25%, witch hazel 50% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70942-135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	50 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SULISOBENZONE (UNII: 1W6L629B4K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE (UNII: V5VD430YW9)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70942-135-03	1 in 1 CARTON	12/10/2021
1		85 g in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	12/10/2021

Labeler - Beyond Health P.A. (026781064)

Registrant - Derma Care Research Labs (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs		116817470	manufacture(70942-135)