FDA.reportPublic FDA data

Lidocaine 4% Anesthetic Cream

Manufacturer
County Line Pharmaceuticals, LLC | Ei LLC
Effective date
2018-10-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:48:16

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

temporarily relieves pain and itching due to: minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations

Dosage and administration

 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

Storage and handling

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.

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

​Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% w/w

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to:

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

Warnings

WARNINGS SECTION

​For external use only.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children.​  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Lidocaine 4%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43199-040-50

​Lidocaine 4%

Topical Anesthetic Cream

FOR INSTITUTIONAL USE ONLY

5 x 5 grams

county line pharmaceuticals, llc

lidocaine5x5cartonlidocaine5x5carton

Lidocaine 4% - kit with Tegaderm Dressings

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

5g-kit5g-kit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43199-040-05GM - Gram43199-040cf2589d0-7a35-4685-9f01-53c74ecd147c12015-05-05
43199-040-15EA - Each43199-040abd0ecad-fb83-440f-888e-29e5e05d491012014-10-03
43199-040-30GM - Gram43199-040d7f8c7af-1213-4bb1-b3e3-6f2af370dc5112015-05-05
43199-040-50GM - Gram43199-040f9b03c05-2a40-454b-85d6-a78b9b438fdd12014-10-03
43199-040-51GM - Gram43199-040aee5887e-bfa2-4e13-83ae-7df630b6997e12015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI2009873
LIDOCAINEACTIVE MOIETY98PI2009873
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L03
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH3
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK313
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGV3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V33
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43199-04043199-040-05, 43199-040-50, 43199-040-15, 43199-040-51, 43199-040-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BENZYL ALCOHOLLKG8494WBHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 156 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31SUSPENSION/ DROPS / OPHTHALMIC0.45 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR144 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTICULAR1 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAMUSCULAR500 mgExact identifier — unii candidate
50 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31GEL / TOPICAL81 mgExact identifier — unii candidate
17 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAVENOUS1620 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / SUBCUTANEOUS225 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE / ORAL450 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31TABLET / ORAL8 mgExact identifier — unii candidate
17 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31LOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTERIAL0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSPRAY / NASAL5 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRALESIONAL20 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31GRANULE, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
17 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRAMUSCULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / ENDOTRACHEAL54 mgExact identifier — unii candidate
50 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31CAPSULE / ORAL50 mgExact identifier — unii candidate
17 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
50 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7e8052d3-efb2-adbf-f2ad-d9ea3da92b4af3ebbf7e-6254-4694-a4fc-1550e9bd2f622018-10-15WarningsExact identifier
spl id: 7e8052d3-efb2-adbf-f2ad-d9ea3da92b4a
spl set id: f3ebbf7e-6254-4694-a4fc-1550e9bd2f62

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.