FDA.reportPublic FDA data

TopCare Pain Relieving Cream

Manufacturer
Topco Associates, LLC | Weeks & Leo Co., Inc. | WEEKS & LEO COMPANY, INC.
Effective date
2026-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:26

Label at a glance#

ProductTopCare Pain Relieving Cream
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily children under 2 years: do not use, consult a doctor.

Storage and handling

store at controlled room temperature 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

INDICATIONS & USAGE SECTION

temporarily relieves minor pain

OTC - PURPOSE SECTION

Topical analgesic

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

In large quantities, particularly over raw surfaces or blistered areas

Stop use

OTC - ASK DOCTOR SECTION

  • condition gets worse
  • symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days

OTC - WHEN USING SECTION

do not get into eyes

OTC - STOP USE SECTION

  • condition gets worse
  • symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days

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 2 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: do not use, consult a doctor.

Other information

STORAGE AND HANDLING SECTION

store at controlled room temperature 20°-25°C (68°-77°F)

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,
C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

RECENT MAJOR CHANGES SECTION

uses:

added temporarily relieves pain.

Directions

Added the required directions

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare Health

Fragrance-free

Pain Relieving Cream

with Lidocaine HCl 4% Topical Analgesic

Maximum Strength

Temporary Relief of Pain

Non-Greasy

Fast Acting

with Aloe

Net Wt 2.7oz (76.5g) CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN1
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD1
1010895lidocaine hydrochloride 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
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
76162-291-02TopCare Pain Relieving Cream1 in 1 CARTONCREAM11
76162-291-02TopCare Pain Relieving Cream76.5 g in 1 BOTTLECREAM76.51

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-29176162-291-02

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
METHYLPARABENA2I8C7HI9TIACT
AMINOMETHYL PROPANOLLU49E6626QIACT
EDETATE DISODIUM7FLD91C86KIACT
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER4ZK9VP326RIACT
DICETYL PHOSPHATE2V6E5WN99NIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
STEARETH-2153J3F32P58IACT
ALCOHOL3K9958V90MIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
WATER059QF0KO0RIACT
CETEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
CAPRYLYL METHICONEQ95M2P1KJLIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
CETETH-20 PHOSPHATE921FTA1500IACT

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
TopCare Pain Relieving CreamLIDOCAINE HCL 4%Topco Associates, LLC4885a7e6-a127-450a-e063-6294a90a4f912026-01-16WarningsExact identifier
ndc (package): 76162-291-02
ndc (product): 76162-291
ndc11 (package): 76162029102
spl id: 4885aa2d-4f27-7603-e063-6394a90a1562
spl set id: 4885a7e6-a127-450a-e063-6294a90a4f91

Reported adverse events (FAERS/openFDA)#

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