LIDOCAINE- lidocaine 4% cream 
AvKARE

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Lidocaine 4% Cream

Active Ingredient:

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

temporarily relieves pain and itching due to:

WARNINGS

For external use only.

When using this product

  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask doctor if

  • Allergic reaction 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 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 degC (68-77 deg.F).

Inactive ingredients

Cetyl alcohol, citric acid, glycerin, glyceryl stearate SE, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, stearyl alcohol, white petrolatum, xanthan gum

30

LIDOCAINE 
lidocaine 4% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42291-399
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MINERAL OIL (UNII: T5L8T28FGP)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-100 STEARATE (UNII: YD01N1999R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PETROLATUM (UNII: 4T6H12BN9U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42291-399-301 in 1 CARTON07/10/2018
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 DrugM01707/10/2018
Labeler - AvKARE (796560394)

Revised: 3/2024
Document Id: 13033771-17bc-7aaf-e063-6294a90a3aae
Set id: 70aace2f-47b4-e961-e053-2991aa0a6367
Version: 8
Effective Time: 20240306
 
AvKARE