RECTAEASE HEMORRHOID RELIEF CREAM- lidocaine cream

RectaEase Hemorrhoid Relief Cream by

Drug Labeling and Warnings

RectaEase Hemorrhoid Relief Cream by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC. 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, ithcing and burning associated with hemorrhoids and other anorectal disorders.

Warning Section

For External Use Only

Stop use and ask a doctor

Rectal bleeding occurs

Condition worsens

Symptoms persist for more than 7 days or clear up and return within a few days

Symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

When using this product

Avoid contact with the eyes

do not use more than directed unless told to do so by a doctor

do not put directly into the rectum by using fingers or any mechanical device or applicator

If Pregnant or Breast Feeding

Ask doctor before use

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

Directions

Directions:

When practical, clean the affected area with mild soaping warm water and rinse thoroughly.

Gently dry by patting or blotting with a toilet tissue or soft cloth before applying.

Adult and children 12 years of age and older, apply to affected area not more than 6 times a day.

Children under 12 years of age: do not use, ask a doctor

Other Information

Store at 20º-25ºC (68º-77ºF)

Inactive Ingredients

Benzyl alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl myristate, Propylene glycol,Trolamine, Vitamin E, polysorbate 80, propylene glycol, purified water

Questions or Comments

Call 1-888-296-9067

Distributed By

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301, USA

1-888-296-9067

www.trifecta-pharma.com

Packaging

INGREDIENTS AND APPEARANCE

RECTAEASE HEMORRHOID RELIEF CREAM 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-070
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
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHOLESTEROL (UNII: 97C5T2UQ7J)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-070-01	1 in 1 BOX	04/19/2021
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	04/19/2021

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)