FDA.reportPublic FDA data

Lidocaine creme

Manufacturer
Kareway Product, Inc.
Effective date
2023-01-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:53:32

Label at a glance#

ProductLidocaine creme
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

adults and children over 12 years: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period AFTER APPLYING, WASH HANDS WITH SOAP AND WATER children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SOUNDBODY

LIDOCAINE

PAIN RELIEVING CREAM

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Purposes

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When using this product

OTC - WHEN USING SECTION

  • Use only as directed. Read and follow all directions and warnings on this label
  • rare cases of serious burns have been reported with products of this type
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch
  • avoid contact with eyes and mucous membranes
  • a transient burning sensation may occur upon application but generally disappears in several days

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, cetearyl alcohol(and)dicetyl phosphate(and)ceteth-10 phosphate, cyclopentasiloxane, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate / sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, SD alcohol 40 (15%), steareth-21, water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOUNDBODY

Lidocaine

Plus Menthol

Pain Relieving Cream

cartoncarton

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67510-0680-12025-01-30C16284748780-12cef2736-62a3-d83d-e063-dadaa90ab31fSOUNDYBODY Lidocaine Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0680-1Lidocaine creme1 in 1 CARTONCREAM14
67510-0680-1Lidocaine creme49.6 g in 1 TUBECREAM49.64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0680LIDOCAINE CREME (LIDOCAINE HCL AND MENTHOL) CREAM [KAREWAY PRODUCT, INC.]4Legacy NDC, 2 package rows20230129_9ee572b6-4f0a-69d5-e053-2995a90aed51.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67510-068067510-0680-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOHEXADECANE918X1OUF1EIACT
POLYSORBATE 60CAL22UVI4MIACT
ALCOHOL3K9958V90MIACT
STEARETH-2153J3F32P58IACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB

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
f3449a7c-6812-4cd1-e053-2995a90a05c89ee572b6-4f0a-69d5-e053-2995a90aed512023-01-27WarningsExact identifier
spl id: f3449a7c-6812-4cd1-e053-2995a90a05c8
spl set id: 9ee572b6-4f0a-69d5-e053-2995a90aed51

Reported adverse events (FAERS/openFDA)#

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