LIDOCAINE 5%- lidocaine 5% cream 
TriMarc Labs

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Lidocaine 5%

Active Ingredient


Lidocaine 5% w/w

Purpose

Topical anesthetic

Use

temporarily relieves pain and itching due to anorectal disorders

WARNINGS:

For external use only

When using this product

  • avoid contact with the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
  • do not put directly in rectum by using fingers or mechanical device
  • do not exceed recommended dosage unless directed by a doctor

Stop use and ask doctor if:

  • allergic reaction occurs
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of the reach of children

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

Directions

  • When practical, clean area with mild soap and warm water and rinse thouroughly
  • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: Consult a doctor

Other Information

  • Store at 25  deg. C (77F); excursions permitted to 15-30 deg. C (59-86F)

    [see USP Controlled Room Temperature].

Inactive ingredients

water, cetyl alcohol, stearic acid, aloe barbadensis leaf juice, simmondsia chinensis (jojoba) seed oil,

lecithin, hexylene glycol, sodium polyacrylate, caprylyl glycol, ethoxydiglycol, potassium sorbate, phenoxyethanol

Lidocaine 5%

68752015 Label

LIDOCAINE 5% 
lidocaine 5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68752-015
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)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
JOJOBA OIL (UNII: 724GKU717M)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68752-015-451 in 1 CARTON04/29/201310/09/2023
145 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/01/201110/09/2023
Labeler - TriMarc Labs (156893695)
Registrant - TriMarc Labs (156893695)
Establishment
NameAddressID/FEIBusiness Operations
TriMarc Labs156893695manufacture(68752-015)

Revised: 10/2023
Document Id: 074efd3b-bebf-8dad-e063-6294a90af4f3
Set id: 6aac0204-dd23-4356-8d8a-9f4c3bdc543d
Version: 6
Effective Time: 20231009
 
TriMarc Labs