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LIPOSOMAL HEMORRHOID MASTER

84735-008 LIPOSOMAL HEMORRHOID MASTER

Approved
Approval ID

34eb651c-abf3-f334-e063-6294a90a6f01

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 12, 2025

Manufacturers
FDA

Hengyang Chuangjiujia Trading Co., Ltd.

DUNS: 977292157

Products 1

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

Lidocaine HCl 4%, Phenylephrine HCl 0.25%

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84735-008
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine HCl 4%, Phenylephrine HCl 0.25%
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 12, 2025
FDA Product Classification

INGREDIENTS (21)

TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
ASIAN GINSENGInactive
Code: CUQ3A77YXI
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
LIDOCAINEActive
Quantity: 4 g in 100 g
Code: 98PI200987
Classification: ACTIB
PYRIDOXINE HCLInactive
Code: 68Y4CF58BV
Classification: IACT
CHAMOMILEInactive
Code: FGL3685T2X
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
TRIETHANOLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
PHENYLEPHRINEActive
Quantity: 0.25 g in 100 g
Code: 1WS297W6MV
Classification: ACTIB
ALOE BARBADENSIS LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
DEXPANTHENOLInactive
Code: 1O6C93RI7Z
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
CARBOMERInactive
Code: 0A5MM307FC
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/12/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/12/2025

Uses. Forthe temporany relief of local and anorectal iching and discomfot asociated with anoreclal isorders and anorectalimammation.
Forthe temporany reief of pain,buring and sorenes.
Temporarily shrinks hemorthoidal tisue, Temporarily reduces the sweling associated with iritation in hemorthoids and other anorectal disorders.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/12/2025

Loca Anesthetic
Vasoconstrictor

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/12/2025

Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/12/2025

Lidocaine HCl 4%

Phenylephrine HCl 0.25%

WARNINGS SECTION

LOINC: 34071-1Updated: 5/12/2025

For external and /or intrarectal use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/12/2025

Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/12/2025

If condition worsens or does not improve within 7 days, consult a doctor.
Do not exceed the recommended daily dosage unless directed by a doctor.
In case of bleeding, consult a doctor promptly.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/12/2025

Keep away from direct sunlight or heat.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/12/2025

Directions: Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/12/2025

Petrolatum
Aloe Barbadensis Leaf Extract
Glycerin
Mineral Oil
Chamomilla Recutita (Matricaria) Flower Extract
Tocopherol
Ascorbic Acid
Pyridoxine HCl
Ginseng Extract
Propylene Glycol
Sodium Hyaluronate
Polysorbate 80
Panthenol
Allantoin
Phenoxyethanol
Ethylhexylglycerin
Carbomer
Triethanolamine
Water

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LIPOSOMAL HEMORRHOID MASTER - FDA Drug Approval Details