Comfort Candy Hemorrhoidal Gel

Manufacturer
BOWLER ESTHETICS, INC | Pure Source, LLC
Effective date
2025-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:08:27

Label at a glance#

ProductComfort Candy Hemorrhoidal
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For the temporary relief of pain, irritation, or burning.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5.00 %
Phenylephrine Hcl 0.25%

Purpose

OTC - PURPOSE SECTION

Anorectal (hemorrhoidal)
Anorectal (vasoconstrictor)

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain, irritation, or burning.

Warnings:

WARNINGS SECTION

For external use only

Do not

OTC - DO NOT USE SECTION

  • exceed the recommended daily dosage unless directed by a doctor. 
  • put this product into the rectum by using your fingers or any mechanical device or applicator. 
  • use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate glad unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

  • If the condition worsens or does not improve within 7 days, consult a doctor. 
  • In case of bleeding, consult a doctor promptly.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR SECTION

  • presently taking a prescription drug for high blood pressure or depression.

Allergy alert


  • Certain persons can develop allergic reactions to ingredients in this product.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding ,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults:

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

Other information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Alcohol, Allantoin, Aloe Barbadensis Leaf Juice, Citric Acid, Dimethyl Sulfone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Water (Aqua), Xanthan Gum

Questions?

OTC - QUESTIONS SECTION

(435-295-4328)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Tube0Label Tube0Label Box0Label Box0

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2621576lidocaine 5 % / phenylephrine HCl 0.25 % Rectal GelPSN1
2621576lidocaine 0.05 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal GelSCD1
2621576lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal GelSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
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bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
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b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
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68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
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49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85956-624-00Comfort Candy Hemorrhoidal30 mL in 1 BOTTLEGEL301
85956-624-00Comfort Candy Hemorrhoidal1 in 1 BOXGEL11

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85956-62485956-624-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
Comfort Candy HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEBOWLER ESTHETICS, INC4951d984-3e86-4eb6-9505-2c506e22fda22025-07-23WarningsExact identifier
ndc (package): 85956-624-00
ndc (product): 85956-624
ndc11 (package): 85956062400
spl id: 3a81b304-c479-81d3-e063-6294a90a653f
spl set id: 4951d984-3e86-4eb6-9505-2c506e22fda2

Reported adverse events (FAERS/openFDA)#

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