LIDOCAINE- lidocaine cream 
Nanjing Cuccess Pharmaceutical Co., Ltd.

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Active Ingredients

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

For the temporary relief of pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Warnings

For external only.

When using this product

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

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop 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

Store at USP controlled room temperature 20-25℃ (68-77°F).

Inactive ingredient

benzyl alcohol, carbomer homopolymer type C 980NF, cholesterol, isopropyl myristate, polysorbate 80, propylene glycol, purified water, soybean lecithin, tocopherol.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

main label

LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83589-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE20 g  in 500 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83589-302-021 in 1 BOX04/04/2024
1500 g in 1 JAR; Type 0: Not a Combination Product
2NDC:83589-302-011 in 1 BOX04/04/2024
2300 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01504/04/2024
Labeler - Nanjing Cuccess Pharmaceutical Co., Ltd. (420793416)
Registrant - Nanjing Cuccess Pharmaceutical Co., Ltd. (420793416)

Revised: 6/2024
Document Id: 1a2084dc-ba1c-22ba-e063-6294a90a03fa
Set id: 1967c259-6e25-6477-e063-6294a90a3b21
Version: 2
Effective Time: 20240605
 
Nanjing Cuccess Pharmaceutical Co., Ltd.