Hemorrhoid Ointment

Hemorrhoid Ointment
SPL v1
SPL
SPL Set ID 102798e6-aa8e-27e6-e063-6394a90aac49
Route
TOPICAL
Published
Effective Date 2024-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Lecithin, Soybean Trolamine Water Carbomer Homopolymer, Unspecified Type Menthol Aloe

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-30

Description

Hemorrhoid Ointment


Medication Information

Warnings and Precautions

For externaand/or intrarectal use only

Indications and Usage

Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burnina, itching).

Temporarily reduces the sweling associated with irritated hemorrhoidal tissue and other anorectal disorders.

Dosage and Administration

Children under 12 years of age consult your pediatrician.

Adults: apply to the affected area up to 3 times daily.

Clean affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.

To use dispensing cap, attach it to tube, lubricate well. then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.

Description

Hemorrhoid Ointment

Section 42229-5

Hemorrhoid Ointment

Section 44425-7

Store at 59* to 77*F to avoid melting

Section 50565-1

Keep out of reach of children. lf swallowed, seek medical help or contact a Poison Contro Center right away.

Section 50566-9

Condition worsens or does not improve within seven (7) days.

Bleeding occurs.

Introduction of applicator into the rectum causes additional pain.

Section 50567-7

Do not exceed recommended daily dosage unless directed by a doctor.

Ask a doctor before use if you have:

Allergies to any of the components of this product.

Difficulty in urination due to enlargement of the prostate gland.

Diabetes: Heart Disease : High Blood Pressure Thyroid Disease.

Presently taking a prescription for high blood pressure or depression.

Section 50570-1

lf pregnant or breast-feeding, ask a health care professional before use

Section 51727-6

Aloe barbadebsis leaf juice (Aloe vera)

Water

Lecithin (Soybean)

Carbomer

Menthol

Triethanolamine

Section 51945-4

Section 55105-1

Topical Anesthetic

Section 55106-9

Lidocaine 5%


Structured Label Content

Indications and Usage (34067-9)

Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burnina, itching).

Temporarily reduces the sweling associated with irritated hemorrhoidal tissue and other anorectal disorders.

Dosage and Administration (34068-7)

Children under 12 years of age consult your pediatrician.

Adults: apply to the affected area up to 3 times daily.

Clean affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.

To use dispensing cap, attach it to tube, lubricate well. then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.

Warnings and Precautions (34071-1)

For externaand/or intrarectal use only

Section 42229-5 (42229-5)

Hemorrhoid Ointment

Section 44425-7 (44425-7)

Store at 59* to 77*F to avoid melting

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowed, seek medical help or contact a Poison Contro Center right away.

Section 50566-9 (50566-9)

Condition worsens or does not improve within seven (7) days.

Bleeding occurs.

Introduction of applicator into the rectum causes additional pain.

Section 50567-7 (50567-7)

Do not exceed recommended daily dosage unless directed by a doctor.

Ask a doctor before use if you have:

Allergies to any of the components of this product.

Difficulty in urination due to enlargement of the prostate gland.

Diabetes: Heart Disease : High Blood Pressure Thyroid Disease.

Presently taking a prescription for high blood pressure or depression.

Section 50570-1 (50570-1)

lf pregnant or breast-feeding, ask a health care professional before use

Section 51727-6 (51727-6)

Aloe barbadebsis leaf juice (Aloe vera)

Water

Lecithin (Soybean)

Carbomer

Menthol

Triethanolamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Anesthetic

Section 55106-9 (55106-9)

Lidocaine 5%


Advanced Ingredient Data


Raw Label Data

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