Lidocaine 4% Cream

Manufacturer
Teligent Pharma, Inc. | Teligent, Inc.
Effective date
2019-01-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:42:19

Label at a glance#

ProductLidocaine 4% Cream
Active ingredientLIDOCAINE
Label structure12 sections

Indications and uses

Lidocaine 4% cream is indicated for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites. Lidocaine 4% cream is not recommended for internal use, in the or near the eyes and in large quantities, particularly over raw surfaces or blistered areas.  

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Lidocaine 4% cream is a non-greasy cream specially formulated with soothing agents, indicated as a topical anesthetic for use on normal intact skin for local analgesia and itching due to minor cuts, minor scrapes, sunburn, minor skin irritations, minor burns and insect bites.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE: Lidocaine (4%)

INACTIVE:

INACTIVE INGREDIENT SECTION

Butylated Hydroxytoluene, Cetostearyl Alcohol, Citric Acid, Edetate Disodium, Light Mineral Oil, Methylparaben, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate and White Petrolatum.

The chemical designation of Lidocaine is 2-(diethylamino)-N(2,6-dimethylphenyl), acetamide. The structure of lidocaine is:


chemical structurechemical structure

MECHANISM OF ACTION

MECHANISM OF ACTION SECTION

Lidocaine 4% cream applied to intact skin provides dermal analgesia by the release of lidocaine from the cream into the epidermis and dermis. Lidocaine is a local anesthetic agent of the amide type. Local anesthetics reversibly block the initiation and conduction of nerve impulses by interfering with the flux of sodium ions through the neuronal membrane. The onset, depth and duration of dermal analgesia provided depend upon the site and duration of application.

INDICATIONS AND USAGE

OTC - PURPOSE SECTION

Lidocaine 4% cream is indicated for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites.

Lidocaine 4% cream is not recommended for internal use, in the or near the eyes and in large quantities, particularly over raw surfaces or blistered areas.  

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Lidocaine 4% cream is contraindicated in patients with sensitivity to amide type local anesthetics or to any component of the product.

WARNINGS

WARNINGS SECTION

For external use only. Avoid contact with the eyes. Do not use over large areas of the body. Do not use for more than seven days unless directed by a doctor. Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Inappropriate use of this product, such as on large areas of the body, application on mucous membranes, or on individuals that are allergic to the amide type anesthetics, may result in serious side effects. Consultation with a doctor before using this product is strongly recommended.

PRECAUTIONS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Repeated doses of lidocaine 4% cream may increase blood levels of lidocaine. Avoid contact with the eyes. If eye contact occurs, immediately wash out the eye with water or saline.

The patient should be aware that dermal analgesia may be accompanied by the block of all sensations in the treated skin. For this reason, the patient should avoid inadvertent trauma to the treated area by scratching, rubbing or exposure to extreme hot or cold temperatures until complete sensation has returned.

DRUG INTERACTIONS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Lidocaine 4% cream should be used with caution in patients receiving Class I antiarrhythmic agents (e.g., tocainide, mexiletine) since the toxic effects are potentially additive and synergistic.

SPL UNCLASSIFIED SECTION

  • 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 of age. Consult a doctor.

HOW SUPPLIED

HOW SUPPLIED SECTION

NDC 52565-122-07 (5 x 5 gram tubes)
NDC 52565-122-15 (15 gram tubes)
NDC 52565-122-30 (30 gram tubes)

Store at USP controlled room temperature 20° to 25°C (68° to 77°F).  

Manufactured by:
Teligent Pharma, Inc.
Buena, New Jersey 08310

PI-122-01
Revised 09/2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 52565-122-15

Lidocaine Cream 4%

Net Wt. 15 grams

For Topical Use Only
Do Not Use in the Eyes

15g carton PDP
15g carton PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN3
1421893lidocaine 40 MG/ML Topical CreamSCD3
1421893lidocaine 4 % Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-122-072023-01-30C16284748780-1f386c64a-2783-0266-e053-dadaa90a7c1aLidocaine 4% Cream
52565-122-152023-01-30C16284748780-1f386c64a-2783-0266-e053-dadaa90a7c1aLidocaine 4% Cream
52565-122-302023-01-30C16284748780-1f386c64a-2783-0266-e053-dadaa90a7c1aLidocaine 4% Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-122-07Lidocaine 4% Cream5 g in 1 TUBECREAM53
52565-122-07Lidocaine 4% Cream5 in 1 CARTONCREAM53
52565-122-15Lidocaine 4% Cream15 g in 1 TUBECREAM153
52565-122-15Lidocaine 4% Cream1 in 1 CARTONCREAM13
52565-122-30Lidocaine 4% Cream1 in 1 CARTONCREAM13
52565-122-30Lidocaine 4% Cream30 g in 1 TUBECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-122LIDOCAINE 4% CREAM (LIDOCAINE) CREAM [TELIGENT PHARMA, INC.]3Legacy NDC, 6 package rows20210910_a3216e25-82bb-4905-ac0b-b2ef4aa32ea0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-122-07GM - Gram52565-1228c153522-d598-4005-958d-b9ed6d7f8adc12019-02-13
52565-122-15GM - Gram52565-122517c9f4a-7bc7-45e5-af04-9c42d090f27912019-02-13
52565-122-30GM - Gram52565-1223e7e43ac-63bf-4487-8268-8abcb3a6184512019-02-13

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52565-12252565-122-07, 52565-122-15, 52565-122-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

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
a8eeed92-d89f-4119-b862-31e1f91f6b21a3216e25-82bb-4905-ac0b-b2ef4aa32ea02019-01-22WarningsExact identifier
spl id: a8eeed92-d89f-4119-b862-31e1f91f6b21
spl set id: a3216e25-82bb-4905-ac0b-b2ef4aa32ea0

Reported adverse events (FAERS/openFDA)#

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