COMFORT CANDY HEMORRHOIDAL- lidocaine, phenylephrine hydrochloride gel

Comfort Candy Hemorrhoidal by

Drug Labeling and Warnings

Comfort Candy Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by BOWLER ESTHETICS, INC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Lidocaine 5.00 %
Phenylephrine Hcl 0.25%

Purpose

Anorectal (hemorrhoidal)
Anorectal (vasoconstrictor)

Uses

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

Warnings:

For external use only

Do not

• 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

• 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

• 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

• 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.

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

If pregnant or breast-feeding ,

ask a health professional before use.

Directions:

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:

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

Inactive ingredients:

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

Questions?

(435-295-4328)

Package Labeling:

INGREDIENTS AND APPEARANCE

COMFORT CANDY HEMORRHOIDAL 
lidocaine, phenylephrine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85956-624
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85956-624-00	1 in 1 BOX	06/20/2025
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	06/20/2025

Labeler - BOWLER ESTHETICS, INC (061481683)

Registrant - Pure Source, LLC (080354456)