HEMORRHOID RELIEF CREAM- lidocaine 5% anorectal cream

Hemorrhoid Relief Cream by

Drug Labeling and Warnings

Hemorrhoid Relief Cream by is a Otc medication manufactured, distributed, or labeled by ALAINA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Lidocaine 5% W/W

Purpose

Local Anesthetic

Uses

helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Warnings

For external use only

When using this product

• use only as directed.
• Avoid contact with eyes.
• do not exceed the recommended dosage unless directed by a doctor. 
• do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

• rectal bleeding occurs. 
• condition worsens or does not improve within 7 days.
• symptoms clear up and occur again within a few days.
• an allergic reaction develops to ingredients in this product.
• symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Adult and children 12 years and over:

• 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 a soft cloth before application of this product.
• apply externally to the affected area up to 6 times a day
• children under 12 years of age: consult a doctor.

Other Information.

• Store between 15°-30° C (59°-86°F).

Inactive Ingredient

Benzyl Alcohol, Carbomer 940, Cholesterol, Isopropyl Myristate, Lecithin, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, Vitamin-E Acetate.

Questions or Comments?

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Ferndale IP, Inc., Owner of the registered trademark RectiCare ®.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hemorrhoid Relief Cream
Lidocaine 5% Anorectal Cream
Helps relieve pain and burning
For temporary relief of itching and discomfort associated with hemorrhoids and other anorectal disorders
Highest lidocaine strength available over-the-counter
Net wt 1oz (30g)

INGREDIENTS AND APPEARANCE

HEMORRHOID RELIEF CREAM 
lidocaine 5% anorectal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73492-712
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 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER 940 (UNII: 4Q93RCW27E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73492-712-28	1 in 1 CARTON	01/28/2022
1		28 g in 1 TUBE; 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	01/28/2022

Labeler - ALAINA HEALTHCARE PRIVATE LIMITED (858720927)

Establishment
Name	Address	ID/FEI	Business Operations
ALAINA HEALTHCARE PRIVATE LIMITED		858720927	manufacture(73492-712)