FDA.reportPublic FDA data

Eha

Manufacturer
Asclemed USA, Inc.
Effective date
2018-11-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:27:06

Label at a glance#

ProductEha
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

For temporary relief of pain and itching and minor skin irritations due to minor cuts and scrapes, sunburns, and minor burns.

Dosage and administration

For adults and children two-years or older, apply externally to the affected area. Do not use more than three to four times per day.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 4%

Purpose

OTC - PURPOSE SECTION

External Anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching and minor skin irritations due to minor cuts and scrapes, sunburns, and minor burns.

Warning

WARNINGS SECTION

For external use only.

Avoid contact with eyes

Stop using this product and ask doctor if

OTC - STOP USE SECTION

  • symptoms last for more than seven days, or clear up and occur again within a few days
  • if redness, irritation, swelling, pain or other symptoms 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

For adults and children two-years or older, apply externally to the affected area. Do not use more than three to four times per day.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: Aqua (Deionized Water), C13-14 Isoparaffin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, M Polyacrylamide, Steric Acid.

Principal Display Panel - 88 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

‘Eha Lotion 4%

Pain Relief Lotion

For Professional Use Only

3 OZ (88 mL)

Distributed by

Enovachem ™

PHARMACEUTICALS

Torrance, CA 90501

(310) 320-0100

Principal Display Panel
Principal Display Panel

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-351-30Eha88 mL in 1 BOTTLELOTION882

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-351EHA (LIDOCAINE HYDROCHLORIDE) LOTION [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 1 package rows20181221_09835640-55c3-4bfa-9ad3-15d37f06e871.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-351-30ML - Milliliter76420-3512a7cba55-bc13-4c9d-b572-1de6e64ae32612016-10-06

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76420-35176420-351-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LAURETH-7Z95S6G8201IACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
STEARIC ACID4ELV7Z65APIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
EhaLIDOCAINE HYDROCHLORIDEAsclemed USA, Inc.09835640-55c3-4bfa-9ad3-15d37f06e8712018-11-01WarningsExact identifier
ndc (package): 76420-351-30
ndc (product): 76420-351
ndc11 (package): 76420035130
spl id: 7d77ecf6-5731-d43e-e053-2991aa0af0db
spl set id: 09835640-55c3-4bfa-9ad3-15d37f06e871

Reported adverse events (FAERS/openFDA)#

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