Lidocaine 4% Anesthetic Cream

Lidocaine by

Drug Labeling and Warnings

Lidocaine by is a Otc medication manufactured, distributed, or labeled by County Line Pharmaceuticals, LLC, Ei LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIDOCAINE- lidocaine cream 
County Line Pharmaceuticals, LLC

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.

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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 older: apply 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43199-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43199-040-50	5 in 1 CARTON	09/02/2014	07/01/2019
1	NDC: 43199-040-05	5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43199-040-15	5 in 1 CARTON	09/02/2014	05/01/2019
2	NDC: 43199-040-05	5 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 43199-040-51	1 in 1 CARTON	09/02/2014	12/01/2019
3		15 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 43199-040-30	1 in 1 CARTON	09/02/2014	09/01/2019
4		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/02/2014	12/01/2019

Labeler - County Line Pharmaceuticals, LLC (015585278)

Establishment
Name	Address	ID/FEI	Business Operations
Ei LLC		105803274	manufacture(43199-040) , analysis(43199-040) , label(43199-040)

Revised: 10/2018

Document Id: 7e8052d3-efb2-adbf-f2ad-d9ea3da92b4a

34390-5

Set id: f3ebbf7e-6254-4694-a4fc-1550e9bd2f62

Version: 5

Effective Time: 20181015

 

County Line Pharmaceuticals, LLC