HEMORRHOID OINTMENTS- lidocaine paste

HEMORRHOID OINTMENTS by

Drug Labeling and Warnings

HEMORRHOID OINTMENTS by is a Otc medication manufactured, distributed, or labeled by Shenzhen Yangan Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Hemorrhoid Ointment

ACTIVE INGREDIENT

Lidocaine 5%

PURPOSE

Topical Anesthetic

INDICATIONS & 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.

WARNINGS

For externaand/or intrarectal use only

WHEN USING

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.

STOP USE

Condition worsens or does not improve within seven (7) days.
Bleeding occurs.
Introduction of applicator into the rectum causes additional pain.

DO NOT USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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.

STORAGE AND HANDLING

Store at 59* to 77*F to avoid melting

INACTIVE INGREDIENT

Aloe barbadebsis leaf juice (Aloe vera)
Water
Lecithin (Soybean)

Carbomer
Menthol
Triethanolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMORRHOID OINTMENTS 
lidocaine paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84023-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
MENTHOL (UNII: L7T10EIP3A)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84023-401-01	1 in 1 BOX	01/30/2024
1		60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/30/2024

Labeler - Shenzhen Yangan Technology Co., Ltd. (419283765)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Yangan Technology Co., Ltd.		419283765	manufacture(84023-401)