RECTAEASE HEMORRHOID RELIEF CREAM- lidocaine cream 
Trifecta Pharmaceuticals USA LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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RectaEase Hemorrhoid Relief Cream

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

To use finger cots: Roll one cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

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

recta-ease-1oz-CDER copy

RECTAEASE HEMORRHOID RELIEF CREAM 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-070-011 in 1 BOX04/19/2021
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/19/2021
Labeler - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 4/2021
 
Trifecta Pharmaceuticals USA LLC