Hemorrhoid And Fissure Cream With Lidocaine 5% Plus Phenylephrine 0.25%

Hemorrhoid And Fissure Cream With Lidocaine 5% Plus Phenylephrine 0.25%
SPL v1
SPL
SPL Set ID 3c81ea45-0baf-8c4b-e063-6394a90ad761
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (0.25 g) Lidocaine (1 g)
Inactive Ingredients
Polysorbate 80

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-06

Description

Lidocaine 5% Phenylephrine HCL 0.25%

Purpose

External Analgesic Vasoconstrictor

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


Medication Information

Purpose

External Analgesic

Vasoconstrictor

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

Description

Lidocaine 5% Phenylephrine HCL 0.25%

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
Section 51945-4

Warnings

For external use only

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)

Active Ingredients

Lidocaine 5%

Phenylephrine HCL 0.25%

Inactive Ingredients

benzyl alcohol, carbomer 940, aloe

barbadensis leaf extract, cholesterol,

hydrogenated lecithin, polysorbate 80,

propylene glycol, tocopheryl acetate,

trolamine, water.

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.


Structured Label Content

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
Section 51945-4 (51945-4)

Purpose

External Analgesic

Vasoconstrictor

Warnings

For external use only

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)

Active Ingredients

Lidocaine 5%

Phenylephrine HCL 0.25%

Inactive Ingredients

benzyl alcohol, carbomer 940, aloe

barbadensis leaf extract, cholesterol,

hydrogenated lecithin, polysorbate 80,

propylene glycol, tocopheryl acetate,

trolamine, water.

When Using This Product (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

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

Stop Use and Ask A Doctor If (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)

Keep out of reach of children.

If swallowed, get medical help or

contact a Poison Control Center.


Advanced Ingredient Data


Raw Label Data

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