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Lidocaine by County Line Pharmaceuticals, LLC

Medically reviewed on November 27, 2017

Dosage form: cream
Ingredients: LIDOCAINE 40mg in 1g
Labeler: County Line Pharmaceuticals, LLC
NDC Code: 43199-040

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 4% Anesthetic Cream

​Drug Facts

Active ingredient

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

temporarily relieves pain and itching due to:

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

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 a doctor if
  • allergic reaction occurs
  • condition worsens or does not improve withing 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 olderapply externally to the affected area up to 3 to 4 times a day
 children under 2 years ask a doctor

Other information
  • May be applied under occlusive dressing.
  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Inactive ingredients

benzyl alcohol, carbomer, lecithin, propylene glycol, purfied water, vitamin E acetate.

Lidocaine 4%

NDC 43199-040-50

​Lidocaine 4%

Topical Anesthetic Cream

FOR INSTITUTIONAL USE ONLY

5 x 5 grams

county line pharmaceuticals, llc

Lidocaine 4% - kit with Tegaderm Dressings

NDC 43199-040-15

​Lidocaine 4%

Topical Anesthetic Cream

FOR INSTITUTIONAL USE ONLY

Five 5 gram tubes + ten 3M TegadermTM Transparent Dressings

county line pharmaceuticals, llc

LIDOCAINE 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43199-040
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
PROPYLENE GLYCOL 
BENZYL ALCOHOL 
.ALPHA.-TOCOPHEROL ACETATE 
EGG PHOSPHOLIPIDS 
Packaging
#Item CodePackage Description
1NDC:43199-040-505 TUBE in 1 CARTON
1NDC:43199-040-055 g in 1 TUBE
2NDC:43199-040-155 TUBE in 1 CARTON
2NDC:43199-040-055 g in 1 TUBE
3NDC:43199-040-511 TUBE in 1 CARTON
315 g in 1 TUBE
4NDC:43199-040-301 TUBE in 1 CARTON
430 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/02/2014
Labeler - County Line Pharmaceuticals, LLC (015585278)
Establishment
NameAddressID/FEIOperations
Ei LLC105803274manufacture(43199-040), analysis(43199-040), label(43199-040)

 
County Line Pharmaceuticals, LLC

← See all Lidocaine brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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