FDA.reportPublic FDA data

TopCare ® Cold & Hot Pain Relieving Cream Topical Analgesic

Manufacturer
Topco Associates, LLC | Garcoa, Inc. | Sigan Industries INC.
Effective date
2022-08-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:50:24

Label at a glance#

ProductTopCare Cold and Hot Pain Relieving Analgesic
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL, UNSPECIFIED FORM
Label structure10 sections

Dosage and administration

Adults and children over 12 years: ◆ Apply to affected area not more than 3 to 4 times daily ◆ AFTER APPLYING, WASH HANDS WITH SOAP AND WATER children under 12 years or younger: ask a doctor

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Lidocaine HCl 4%Topical analgesic
Menthol 1%Topical analgesic

Use

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 carton
  • rare cases of serious burns have been reported with products of this type
  • do not bandage or apply local heat (such as heating pads) to the area of 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

Discontinue use and consult a doctor if

SPL UNCLASSIFIED 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

  • Apply to affected area not more than 3 to 4 times daily
  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children under 12 years or younger: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl Acrylate crosspolymer, alcohol denat., aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, polysorbate 60, steareth-21, water.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare®
health

COMPARE TO ICY HOT® ACTIVE INGREDIENTS*

MAXIMUM STRENGTH LIDOCAINE

Cold & Hot
Pain Relieving
Lidocaine Cream

4% Lidocaine • 1% Menthol

LIDOCAINE 4% / TOPICAL ANALGESIC
MENTHOL 1% / TOPICAL ANALGESIC

  • Helps to Numb Away Pain
  • Non-Greasy
  • Maximum Strength External
    Analgesic with 4% Lidocaine

NET WT 2.7 OZ (77 g)

PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton
PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595624lidocaine HCl 4 % / menthol 1 % Topical CreamPSN5
1595624lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical CreamSCD5
1595624lidocaine hydrochloride 4 % / menthol 1 % Topical CreamSY5

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
76162-180-012025-01-30C16284748780-12cef2736-802a-d83d-e063-dadaa90ab31fTopCare ® Cold & Hot Pain Relieving Cream Topical Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-180-01TopCare Cold and Hot Pain Relieving Analgesic1 in 1 CARTONCREAM15
76162-180-01TopCare Cold and Hot Pain Relieving Analgesic77 g in 1 BOTTLECREAM775

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-180TOPCARE COLD AND HOT PAIN RELIEVING ANALGESIC (LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM) CREAM [TOPCO ASSOCIATES, LLC]5Legacy NDC, 2 package rows20220814_e5ed6c88-5b78-449a-adb6-861d6f1d1f4a.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-18076162-180-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
C30-45 Alkyl Cetearyl Dimethicone Crosspolymer4ZK9VP326RIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
Ceteth-20 Phosphate921FTA1500IACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
Dimethicone92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
Ethylhexylglycerin147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
Isohexadecane918X1OUF1EIACT
PhenoxyethanolHIE492ZZ3TIACT
Polysorbate 60CAL22UVI4MIACT
Steareth-2153J3F32P58IACT
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
5d5565af-f998-489d-9442-a33ec6679d95e5ed6c88-5b78-449a-adb6-861d6f1d1f4a2022-08-02WarningsExact identifier
spl id: 5d5565af-f998-489d-9442-a33ec6679d95
spl set id: e5ed6c88-5b78-449a-adb6-861d6f1d1f4a