DR. BUTLER HEMORRHOID TREATMENT- phenylephrine hydrochloride 0.25%, witch hazel 50% spray 
Beyond Health P.A.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Doctor Butler's Hemorrhoid Treatment Spray

Phenylephrine HCl 0.25%, Witch Hazel 50%

Vasoconstrictor, Astringent

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

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.

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

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.

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

Carton

DR. BUTLER HEMORRHOID TREATMENT 
phenylephrine hydrochloride 0.25%, witch hazel 50% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-135
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL50 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70942-135-031 in 1 CARTON12/10/2021
185 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34612/10/2021
Labeler - Beyond Health P.A. (026781064)
Registrant - Derma Care Research Labs (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs116817470manufacture(70942-135)

Revised: 12/2021
Document Id: d2d1c81c-6444-c4b7-e053-2995a90a14d7
Set id: d2d1c81c-6443-c4b7-e053-2995a90a14d7
Version: 1
Effective Time: 20211210
 
Beyond Health P.A.