FDA.reportPublic FDA data

Lidocream Plus

Manufacturer
AEC Consumer Products, LLC
Effective date
2022-02-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:00

Label at a glance#

ProductLidocream Plus
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

• Adults and children over 12 years: Apply as needed to affected areas 3-4 times a day. Consult a physician if pain persists.  • Children 12 years of younger: consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 4%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Use

INDICATIONS & USAGE SECTION

• For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use:  • in large quantities, particularly over raw or blistered surfaces  • for more than one week without consulting a doctor

When using this product: • use only as directed  • avoid contact with the eyes  • do not bandage or apply local heat (such as heating pads) to the area of use

Stop use and ask a doctor if: • condition worsens  • symptoms persist more than 7 days  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

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 over 12 years: Apply as needed to affected areas 3-4 times a day. Consult a physician if pain persists.  • Children 12 years of younger: consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Arnica Montana Flower, Astaxanthin, Benzyl Alcohol, Bergamot Oil, Butylated Hydroxytoluene, C13-14 Isoparaffin, Carbomer, Cetostearyl Alcohol, Cyclomethicone, Diethylene Glycol Monoethyl Ether, Dimethicone, Dimethiconol, Dimethyl Sulfone, Edetate Sodium, Emu Oil, Glycerin, Glyceryl Stearate Se, Indian Frankincense, Isopropyl Palmitate, Laureth-7, Levomenol, N-Acetyl-Glucosamine Thiazoline, Peg-100 Stearate, Phenoxyethanol, Polyacrylamide, Polyquaternium-10, Potassium Sorbate, Propylene Glycol, Salicylic Acid, Sodium Hydroxide, Stearic Acid, Tea Tree Oil, Tocopherol, Trolamine, Turmeric Oil, Vaccinium Myrtillus Anthocyanosides, Vitamin A Palmitate, Water

Questions?

OTC - QUESTIONS SECTION

1-888-AEC-3344 (1-888-232-3344)

SPL UNCLASSIFIED SECTION

ADVANCING PAIN RELIEF®

INFUSED WITH Soothing Botanicals

4% Lidocaine Maximum Strength

TOPICAL ANALGESIC

pain relief cream

AEC Consumer Products

Made in the U.S.A.

Manufactured Exclusively for AEC Consumer Products

135 Airport Road, Fayetteville, NC 28306

www.shoplidocream.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN1
2597529Lidocream Plus 4 % Topical CreamPSN1
2597529lidocaine hydrochloride 40 MG/ML Topical Cream [Lidocream]SBD1
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD1
1010895lidocaine hydrochloride 4 % Topical CreamSY1
2597529Lidocream Plus 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
86089-200-012024-01-30C16284748780-11030e365-66fa-111a-e063-dadaa90a10e2Lidocream ® ​ Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86089-200-01Lidocream Plus96.4 g in 1 TUBECREAM96.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86089-200LIDOCREAM PLUS (LIDOCAINE HYDROCHLORIDE) CREAM [AEC CONSUMER PRODUCTS, LLC]1Legacy NDC, 1 package rows20220401_a959bdfe-971e-4a14-af7d-cf366e65a1fb.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86089-20086089-200-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALLANTOIN344S277G0ZIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ASTAXANTHIN8XPW32PR7IIACT
BENZYL ALCOHOLLKG8494WBHIACT
BERGAMOT OIL39W1PKE3JIIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CYCLOMETHICONENMQ347994ZIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE 200RGS4T2AS00IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
EDETATE SODIUMMP1J8420LUIACT
EMU OIL344821WD61IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LAURETH-7Z95S6G8201IACT
LEVOMENOL24WE03BX2TIACT
N-ACETYL-GLUCOSAMINE THIAZOLINEML5FHL557AIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
POLYQUATERNIUM-10 (400 MPA.S AT 2%)HB1401PQFSIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM HYDROXIDE55X04QC32IIACT
STEARIC ACID4ELV7Z65APIACT
TEA TREE OILVIF565UC2GIACT
TOCOPHEROLR0ZB2556P8IACT
TROLAMINE9O3K93S3TKIACT
TURMERIC OIL6KGS8SP16UIACT
VACCINIUM MYRTILLUS ANTHOCYANOSIDESR911H793SUIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
WATER059QF0KO0RIACT

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
633e570f-9563-4058-9455-6f62626e5a7fa959bdfe-971e-4a14-af7d-cf366e65a1fb2022-02-28WarningsExact identifier
spl id: 633e570f-9563-4058-9455-6f62626e5a7f
spl set id: a959bdfe-971e-4a14-af7d-cf366e65a1fb

Reported adverse events (FAERS/openFDA)#

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