HEMORRHOID AND FISSURE CREAM WITH LIDOCAINE 5% PLUS PHENYLEPHRINE HCL 0.25%- lidocaine 5% plus phenylephrine hcl 0.25% cream cream

Hemorrhoid and Fissure Cream with Lidocaine 5% plus Phenylephrine HCL 0.25% by

Drug Labeling and Warnings

Hemorrhoid and Fissure Cream with Lidocaine 5% plus Phenylephrine HCL 0.25% by is a Otc medication manufactured, distributed, or labeled by Mohnark Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 5%

Phenylephrine HCL 0.25%

Purpose

External Analgesic

Vasoconstrictor

Warnings

For external use only

When using this product

When using this product
avoid contact with eyes
do not exceed recommended
dosage unless directed by a doctor
do not put this product into the
rectum by using fingers or any
mechanical device or applicato

Stop use and ask a doctor if

Stop use and ask a doctor if
rectal bleeding occurs
condition worsens or does not
improve within 7 days
allergic reaction occurs
symptom being treated does not
subside or if redness, irritation,
swelling, pain or other symptoms
develop or increase
symptoms clear up and return within
a few days

Keep out of reach of children

Keep out of reach of children.
If swallowed, get medical help or
contact a Poison Control Center.

Directions

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 soft cloth before applying.
Adults and children 12 years and older: apply externally to the affected
area up to 6 times a day.
Children under 12 years of age: consult a doctor.

Other Information

Store at USP controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients

benzyl alcohol, carbomer 940, aloe
barbadensis leaf extract, cholesterol,
hydrogenated lecithin, polysorbate 80,
propylene glycol, tocopheryl acetate,
trolamine, water.

Uses

• temporary relief of anorectal itching and discomfort associated with hemorrhoids and other anorectal disorders
• for the temporary relief of pain, soreness or burning
• temporarily reduces the swelling associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue

Dosage and Administration

adults, when practical, cleanse the affected area by pattig or blotting with an appropriate cleansing pad

gently dry by patting or blotting with toie tissue or soft cloth before application of this product

apply externally to the affected area up to 4 times daily

chidren under 12 years of age, consult a doctor

Uses

temporary relief of anorectal itching and discomfort associated with hemorrhoids and other anorectal disorders

for the temporary relief of pain, soreness or burning

temporarily reduces the swelling associated with hemorrhoids

temporarily shrinks hemorrhoidal tissue

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOID AND FISSURE CREAM WITH LIDOCAINE 5% PLUS PHENYLEPHRINE HCL 0.25% 
lidocaine 5% plus phenylephrine hcl 0.25% cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73715-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	0.25 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)	1 g  in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73715-007-01	30 g in 1 TUBE; Type 0: Not a Combination Product	01/06/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/06/2025

Labeler - Mohnark Pharmaceuticals Inc (117013830)