LIDOCAINE ANORECTAL- lidocaine cream 
Patrin Pharma Inc.

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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Lidocaine 5% Anorectal Cream

Drug Facts

Active Ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

Temporarily relieves pain and itching due to anorectal disorders

Warnings

When using this product

Stop use and ask a doctor if

  • Rectal bleeding occurs
  • Condition worsens or does not improve within 7 days
  • Allergic reaction occurs
  • Redness, irritation, swelling, pain or other symptoms begin or increase
  • Symptoms clear up and return within a few days

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

Directions

Other information

Inactive ingredients

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

Questions?

Call 800-936-3088

PRINCIPAL DISPLAY PANEL - 15 gram Tube Carton

NDC 39328-025-15

Lidocaine
5%
Anorectal Cream

PATRIN
PHARMA

NET WT. 15 grams

PRINCIPAL DISPLAY PANEL - 15 gram Tube Carton
LIDOCAINE ANORECTAL 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39328-025
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Benzyl Alcohol (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (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)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:39328-025-151 in 1 CARTON11/01/2018
115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:39328-025-301 in 1 CARTON11/01/2018
230 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34611/01/2018
Labeler - Patrin Pharma Inc. (806841677)

Revised: 4/2022
Document Id: a01912cb-9188-4002-8300-8daeaccf2539
Set id: 456d41fe-8449-4980-9291-d7a3b65a900d
Version: 1
Effective Time: 20220414
 
Patrin Pharma Inc.