Health One Pain Relief Cream with Lidocaine 4%

Manufacturer
ONE2ZEE LIMITED LIABILITY COMPANY
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:19:48

Label at a glance#

ProductHealth One Pain Relief Cream with Lidocaine 4%
Active ingredientLIDOCAINE
Label structure2 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 4%

Purpose

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 puncture wounds
  • on large areas of the body or on cut, irritated or swollen skin
  • 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 carton.
  • do not allow contact with the eyes and mucous membranes
  • do not bandage or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
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
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

children 12 years and younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer,, Aloe Vera Leaf Juice, Trolamine, C30-45 alkyl cetearyl dimethicone crosspolymer, Cetearyl Alcohol, Dimethocane, Edetate Disodium, Ethylhexylglycerin, Glyceryl Monostearate, Methylparaben, Isopropyl Alcohol, Steareth-21, Purified Water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
55629-029-04Health One Pain Relief Cream with Lidocaine 4%113.4 g in 1 BOTTLECREAM113.41

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55629-02955629-029-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
Health One Pain Relief Cream with Lidocaine 4%PAIN RELIEF CREAM WITH LIDOCAINE 4%ONE2ZEE LIMITED LIABILITY COMPANY46a2276f-9da0-4e41-92f0-b17c302c72222025-12-03WarningsExact identifier
ndc (package): 55629-029-04
ndc (product): 55629-029
ndc11 (package): 55629002904
spl id: 24ec1555-79e0-4f3c-9c3d-aace9c8390eb
spl set id: 46a2276f-9da0-4e41-92f0-b17c302c7222

Reported adverse events (FAERS/openFDA)#

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