RECTASMOOTHE- lidocaine 5% cream 
Leading Pharma, 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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Lidocaine 5%

Active Ingredient


Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

WARNINGS:

For external use only.

When using this product

  • avoid contact with the eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any other mechanical device or applicator

Stop use and ask doctor if

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

Keep out of the reach of children

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

Directions

Other Information

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

cetyl alcohol, glyceryl monostearate SE, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum, white wax

Lidocaine 5%

Label
Carton
RECTASMOOTHE 
lidocaine 5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69315-301
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
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69315-301-301 in 1 CARTON05/15/2016
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/01/2011
Labeler - Leading Pharma, LLC (079575060)
Registrant - Leading Pharma, LLC (079575060)
Establishment
NameAddressID/FEIBusiness Operations
Lyne Laboratories, Inc.053510459MANUFACTURE(69315-301)

Revised: 12/2017
Document Id: 97a3ef32-4387-45ae-80b9-faceaf833a9c
Set id: 78120481-b780-4e41-885d-11e424d1f717
Version: 2
Effective Time: 20171223
 
Leading Pharma, LLC