RECTOPROTECT- lidocaine cream 
Akron Pharma Inc.

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RectoProtect (Lidocaine 5% Anorectal Cream)

Pain Relief for Hemorrhoids & Other Anorectal Disorders

Active ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

temporarily relieves pain and itching due to anorectal disorders

Directions

Warnings

When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor if

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

Other information

Inactive ingredients

Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purifed Water, Trolamine and Vitamin E Acetate.

Questions or comments?

Call toll-free 1-877-255-6999

Manufactured for:

Akron Pharma Inc.

Fairfield, Nj 07004

www.akronpharma.com

5-15-1

5-15-2

5-30-1

5-30-2

RECTOPROTECT 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Product Characteristics
Colorwhite (clear gel) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-0050-11 in 1 CARTON11/03/2023
15 g in 1 PACKAGE; Type 0: Not a Combination Product
2NDC:71399-0050-21 in 1 CARTON11/03/2023
230 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/03/2023
Labeler - Akron Pharma Inc. (067878881)

Revised: 11/2023
Document Id: 4419487a-26f7-4df7-8683-6d562faf81af
Set id: 1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb
Version: 2
Effective Time: 20231108
 
Akron Pharma Inc.