Dr.Harry COMFORT ZONE Cream

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-03-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:29

Label at a glance#

ProductDr.Harry COMFORT ZONE Cream
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, LIDOCAINE
Label structure13 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% Phenylephrine HCl 0.25%

Purpose

OTC - PURPOSE SECTION

Analgesic (pain relief) Vasoconstrictor

Use

INDICATIONS & USAGE SECTION

Temporarily shrink hemorrhoidal tissue, relieving pain,soreness, burning, itching, and discomfort associated with external hemorrhoids.

Warnings

WARNINGS SECTION

For external use only, including the skin around the anal canal

Do not use

OTC - DO NOT USE SECTION

Ask doctor if you have:Allergies ,Prostate/urination issues, Diabetes/heart/thyroid conditions,On blood pressure or depression meds.

When Using

OTC - WHEN USING SECTION

When using this Do not exceed daily dosage without doctor's direction.
With applicators, apply only to external anal skin

Stop Use

OTC - STOP USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Active ingredient

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2529640lidocaine 4 % / phenylephrine hydrochloride 0.25 % Rectal CreamPSN1
2529640lidocaine 40 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD1
2529640lidocaine 4 % / phenylephrine hydrochloride 0.25 % Rectal CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136979843981422GTIN-13: 6979843981422
EAN-13: 6979843981422
GTIN storage (14 digits): 06979843981422
874ea9e00d6b4314a0be523dfc1af616.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-162-01Dr.Harry COMFORT ZONE Cream20 g in 1 TUBECREAM201

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-16285248-162-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Harry COMFORT ZONE CreamLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% COMFORT ZONE CREAMJiangxi Yudexi Pharmaceutical Co., LTD4d32b89f-72e8-bc93-e063-6394a90a0bc82026-03-17WarningsExact identifier
ndc (package): 85248-162-01
ndc (product): 85248-162
ndc11 (package): 85248016201
spl id: 4d32b89f-72e9-bc93-e063-6394a90a0bc8
spl set id: 4d32b89f-72e8-bc93-e063-6394a90a0bc8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.