LIDOCAINE- lidocaine 5% cream 
AvKARE

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.

----------

Lidocaine 5% Cream

Active Ingredient:

Lidocaine 5% w/w

Purpose

Topical anesthetic

Uses

temporarily relieves pain and itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites

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

  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years of age: Consult a doctor.

Other Information

Store at USP controlled room temperature 20-25 degC (68-77 deg.F).

Inactive ingredients

Ceteareth-6, ceteareth-25, cetyl alcohol, methylparaben, paraffin, propylene glycol, propylparaben, purified water, stearyl alcohol, and xanthan gum.

NDC 42291-400-30
Lidocaine
5%
Cream
Topical Anesthetic Cream
Net Wt. 30 gm

Drug Facts
Active ingredient Purpose
Lidocaine 5% w/w
............................Topical anesthetic
Uses
Temporarily relieves pain and
itching due to:
❚ minor cuts ❚ minor scrapes
❚ sunburn ❚ minor burns
❚ minor skin irritations
❚ insect bites
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 ares
Stop use and ask a 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
❚ Adults and children 2 years
and older: Apply externally to
the affected area up to 3-4 times
daily.
❚ Children under 2 years of age:
Consult a physician
Other Information
❚ Store at USP controlled room
temperature 20°-25°C
(68° - 77°F)
Inactive Ingredients
Ceteareth-6, ceteareth-25, cetyl
alcohol, methylparaben, paraffin,
propylene glycol, propylparaben,
purified water, stearyl alcohol,
xanthan gum.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
AV 03/18 Rev: 03/18

Label 1

Label 2

LIDOCAINE 
lidocaine 5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42291-400
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
CETEARETH-6 (UNII: 2RJS3559D3)  
CETEARETH-25 (UNII: 8FA93U5T67)  
PARAFFIN (UNII: I9O0E3H2ZE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42291-400-301 in 1 CARTON07/11/201801/03/2023
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 not finalpart34807/11/201801/03/2023
Labeler - AvKARE (796560394)

Revised: 1/2023
 
AvKARE