Lidocaine 4% Cream

Manufacturer
Rugby Laboratories | Teligent, Inc.
Effective date
2020-03-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:28:00

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.

MECHANISM OF ACTION

MECHANISM OF ACTION SECTION

Lidocaine 4% cream applies 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 0536-1281-28 (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

Distributed by:
RUGBY® LABORATORIES
17177 N. Laurel Park Dr., Suite 233
Livonia, MI 48152


Revised 01/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby® 

NDC 0536-1281-28

Lidocaine Cream 4%

Net Wt. 30 grams

For Topical Use Only
Do Not Use in the Eyes

30 g carton PDP
30 g carton PDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-1281-282024-11-20C16284748780-1f386c64a-1927-0266-e053-dadaa90a7c1aLidocaine 4% Cream
0536-1281-282023-01-30C16284748780-1f386c64a-1927-0266-e053-dadaa90a7c1aLidocaine 4% Cream

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1281-28GM - Gram0536-128123a98c71-c54c-40c6-a530-142a0c1bb64c12020-07-13

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
0536-12810536-1281-28

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
66692881-80cc-4cc3-82b0-ab8946bae60c21ea06f4-813e-419e-9b87-1eb04d48097e2024-11-20WarningsExact identifier
spl set id: 21ea06f4-813e-419e-9b87-1eb04d48097e

Reported adverse events (FAERS/openFDA)#

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