Active Ingredients
Lidocaine HCl 5%
Phenylephrine HCl 0.25%
Witch Hazel 50%
Dr Butlers Advanced Hemorrhoid Relief Spray
FDA Label NDC 70942-127
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 Dr Butlers Advanced Hemorrhoid Relief (NDC 70942-127). 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 active ingredients, purpose, uses, warnings, flammable, do not use, when using this product, ask a doctor or pharmacist before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Vasoconstrictor
Astrigent
Uses
- temporary relief of anorectal itching and discomfort associated with hemorrhoids and other anorectal disorders
- for the temporary relief of pain, soreness or burning
- temporarily reduces the swelling associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
Warnings
For external use only.
Flammable
Do not use whie smoking or near heat or flame.
Do Not Use
in large quantities, particularly over raw surfaces or blistered areas. Do not exceed recommended dosage unless directed by a doctor.
When Using This Product
- keep out of eyes. Rinse eyes with water to remove
- do not put this product in the rectum by using fingers or any mechanical device or applicator
Ask A Doctor Or Pharmacist Before Use If You Have
- heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland
- are presently taking a prescription drug for high blood pressure or depression
Stop Use And Ask A Doctor If
- condition worsens or does not improve within seven (7) days
- bleeding occurs
- an allergic reaction develops
- the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or icrease
If Pregnant Or Breastfeeding
ask a health professioal before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults, when practical, cleanse the affected area by pattig or blotting with an appropriate cleansing pad
- gently dry by patting or blotting with toie tissue or soft cloth before application of this product
- shake well before using
- hold 3 to 6" away from rectal area, spray to moisten and then wipe off excess, if desired
- apply externally to the affected area up to 4 times daily
- chidren under 12 years of age, consult a doctor
Other Information
- store at 15°-30°C (59°-86°F)
- contents under pressure. Do not puncture or incinerate
Inactive Ingredients
aesculus hippocastanum (horse chestnut) extract
alcohol
aloe barbadensis leaf extract
benzophenone-4
benzyl alcohol
calendula officinalis flower extract
carya ovata bark extract
centella asiatica extract
chamomilla recutita (matricaria) flower extract
curcuma longa (tumeric) root extract
disodium EDTA
epilobium angustifolium extract
ethylhexylglycerin
eucalyptus globulus leaf oil
glycerin
hammamelis virginiana (witch hazel) leaf extract
helichrysum italicum extract
hydroxyethylcellulose
lavandula angustifolia (lavender) flower extract
lysine HCl
melaluca alternifolia (tea tree) leaf extract
mentha piperita (peppermint) oil
olea europaea (olive) leaf extract
panax ginsing root extract
polysorbate 40
propylene glycol
rosmarinus officinalis (rosemary) leaf extract
sodium citrate
sodium hyaluronate
tocopherol
tocopherol acetate
water
5Oz / 142G Can
Pdp (70942 127 05)
* Please review the disclaimer below.
