MedPath

SERYNTH HEMORRHOID

84010-121

Approved
Approval ID

35c9c5e5-300f-08f1-e063-6394a90a7d66

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

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
NDC Product Code84010-121
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine 4%, Phenylephrine HCL 0.25%, HEMORRHOID
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (8)

ALOEInactive
Code: V5VD430YW9
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
THYMOLInactive
Code: 3J50XA376E
Classification: IACT
CHLORHEXIDINE ACETATEInactive
Code: 5908ZUF22Y
Classification: IACT
LIDOCAINEActive
Quantity: 4 g in 100 g
Code: 98PI200987
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 0.25 g in 100 g
Code: 04JA59TNSJ
Classification: ACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
BORNEOLInactive
Code: M89NIB437X
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

PRINCIPAL DISPLAY PANEL

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/23/2025

Use

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/23/2025

Active Ingredient

Lidocaine 4%

Phenylephrine HCL 0.25%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/23/2025

Purpose

Analgesic (pain relief) Vasoconstrictor

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2025

Warnings

For external use only, including the skin aroundthe anal canal

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/23/2025

Do not use

Do not put this product into the rectum.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/23/2025

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

LOINC: 50566-9Updated: 5/23/2025

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

LOINC: 50569-3Updated: 5/23/2025

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

LOINC: 50565-1Updated: 5/23/2025

Keep Out Of Reach Of Children

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2025

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

LOINC: 44425-7Updated: 5/23/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/23/2025

Inactive ingredients

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

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SERYNTH HEMORRHOID - FDA Drug Approval Details