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FDA Approval

SERYNTH HEMORRHOID

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Effective Date
May 23, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Lidocaine(4 g in 100 g)
Phenylephrine(0.25 g in 100 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Jiangxi Hemei Pharmaceutical Co., Ltd

Jiangxi Hemei Pharmaceutical Co., Ltd

724892056

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

SERYNTH HEMORRHOID

Product Details

NDC Product Code
84010-121
Application Number
M017
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
May 23, 2025
ALOEInactive
Code: V5VD430YW9Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
THYMOLInactive
Code: 3J50XA376EClass: IACT
CHLORHEXIDINE ACETATEInactive
Code: 5908ZUF22YClass: IACT
LidocaineActive
Code: 98PI200987Class: ACTIBQuantity: 4 g in 100 g
Code: 04JA59TNSJClass: ACTIBQuantity: 0.25 g in 100 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FCClass: IACT
BORNEOLInactive
Code: M89NIB437XClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

1


INDICATIONS & USAGE SECTION

Use

Temporarily shrink hemorrhoidal tissue, relieving pain,soreness, burning, itching, anddiscomfort associated with hemorrhoids.

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.


WARNINGS SECTION

Warnings

For external use only, including the skin aroundthe anal canal


STORAGE AND HANDLING SECTION

Other information

If pregnant or breast-feeding, ask a health care professional before use.


OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine 4%

Phenylephrine HCL 0.25%

OTC - PURPOSE SECTION

Purpose

Analgesic (pain relief) Vasoconstrictor

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.

OTC - DO NOT USE SECTION

Do not use

Do not put this product into the rectum.

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 - 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.


INACTIVE INGREDIENT SECTION

Inactive ingredients

Borneol,Carbomer Homopolymer,Chlorhexidine Acetate ,Glycerin, Thymol, Aloe


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