Active Ingredient
Lidocaine 4% Phenylephrine HCl 0.25%
Borneol,Carbomer Homopolymer,Chlorhexidine Acetate ，Glycerin, Thymol, Aloe
Dr.harry Comfort Zone Cream
FDA Label NDC 85248-162
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Dr.harry Comfort Zone Cream (NDC 85248-162). 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 ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Analgesic (pain relief) Vasoconstrictor
Use
Temporarily shrink hemorrhoidal tissue, relieving pain,soreness, burning, itching, and discomfort associated with external hemorrhoids.
Warnings
For external use only, including the skin around the anal canal
Do Not Use
Ask doctor if you have:Allergies ,Prostate/urination issues, Diabetes/heart/thyroid conditions,On blood pressure or depression meds.
When Using
When using this Do not exceed daily dosage without doctor's direction.
With applicators, apply only to external anal skin
Stop Use
Stop use and ask a doctor if condition worsens
or does not improve within seven 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 increase. If pregnant or breast-feeding, ask a health care professional before use.
Ask Doctor
Stop use and ask a doctor if condition worsens
or does not improve within seven 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 increase. If pregnant or breast-feeding, ask a health care professional before use.
Keep Oot Of Reach Of Children
If swallowed, seek medical help or contact a Poison Control Center right away.
Directions
Children under 12 years of age consult your
pediatrician.Adults: apply to affected area up to 3 times daily.
Then Thoroughly cleanse dispensing cap after
use with mild soap and warm water and rinse thoroughly.
Other Information
If swallowed, seek medical help or contact a Poison Control Center right away.
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