SERYNTH HEMORRHOID
84010-121
35c9c5e5-300f-08f1-e063-6394a90a7d66
HUMAN OTC DRUG LABEL
May 23, 2025
Jiangxi Hemei Pharmaceutical Co., Ltd
DUNS: 724892056
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine 4%, Phenylephrine HCL 0.25%, HEMORRHOID
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Use
Temporarily shrink hemorrhoidal tissue, relieving pain,soreness, burning, itching, anddiscomfort associated with hemorrhoids.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Lidocaine 4%
Phenylephrine HCL 0.25%
OTC - PURPOSE SECTION
Purpose
Analgesic (pain relief) Vasoconstrictor
WARNINGS SECTION
Warnings
For external use only, including the skin aroundthe anal canal
OTC - DO NOT USE SECTION
Do not use
Do not put this product into the rectum.
OTC - WHEN USING SECTION
When Using
When using this product do not exceed recommended daily dosage unless directed by a doctor, when using finger cots or an applicator, apply externally or the skin of the anal canal only.
OTC - STOP USE SECTION
Stop Use
Ask a doctor before use if you have allergies to any of the components of this product, difficulty in urination due to enlargement of the prostate gland, diabetes, heart disease, high blood pressure, thyroid disease, or presently taking a prescription for high blood pressure or depression.
OTC - ASK DOCTOR SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep Out Of Reach Of Children
If swallowed, seek medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
Children under 12 years of age consult your pediatrician. Adults: apply to
affected area up to 3 times daily.Clean affected area with mild soap and warm
water, rinse thoroughly, and then gently dry (patting or blotting) with tissue
or soft cloth before use.
To use dispensing cap, attach it to tube, lubricate well then gently insert
part way into anus and squeeze tube to deliver medication. Thoroughly cleanse
dispensing cap after use with mild soap and warm water and rinse thoroughly.
STORAGE AND HANDLING SECTION
Other information
If pregnant or breast-feeding, ask a health care professional before use.
INACTIVE INGREDIENT SECTION
Inactive ingredients
Borneol,Carbomer Homopolymer,Chlorhexidine Acetate ,Glycerin, Thymol, Aloe