FDA.reportPublic FDA data

Walgreens Cool n Heat Lidocaine

Manufacturer
Walgreens Co | Derma Care Research Labs, LLC
Effective date
2023-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:46

Label at a glance#

ProductWalgreens Cool n Heat Lidocaine
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

OTC - PURPOSE SECTION

Topical analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

WARNINGS SECTION

For external use only.

Flammable.Keep away from fire or flame.

Do not use inlarge quantities, particularly over raw surfaces or blistered areas.

When using this product

  • avoid contact with eyes. In case of contact with eyes, flush thoroughly with water
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again with a few days
  • redness or irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Clean affected area before applying product. Adults and children 12 years and older, apply to affected area not more than 3 to 4 times daily. Children under 12 years old, ask a doctor.

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., aloe barbadensis leaf extract, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, methylparaben, steareth-21 water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010077lidocaine HCl 4 % Topical GelPSN2
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD2
1010077lidocaine hydrochloride 4 % Topical GelSY2

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
0363-7801-02Walgreens Cool n Heat Lidocaine71 g in 1 BOTTLE, PLASTICGEL712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7801WALGREENS COOL N HEAT LIDOCAINE (LIDOCAINE HCL 4%) GEL [WALGREENS CO]2Current NDC, 1 package rows20231228_0681c6c5-5a8b-ea9e-e063-6394a90a83bc.zip

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
0363-78010363-7801-02

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
WATER059QF0KO0RIACT
DIMETHICONE 200RGS4T2AS00IACT
EDETATE DISODIUM7FLD91C86KIACT
ALOE VERA LEAFZY81Z83H0XIACT
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER4ZK9VP326RIACT
CETETH-20 PHOSPHATE921FTA1500IACT
METHYLPARABENA2I8C7HI9TIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
ALCOHOL3K9958V90MIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
STEARETH-2153J3F32P58IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
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
Walgreens Cool n Heat LidocaineLIDOCAINE HCL 4%Walgreens Co0681c6c5-5a8b-ea9e-e063-6394a90a83bc2023-12-27WarningsExact identifier
ndc (package): 0363-7801-02
ndc (product): 0363-7801
ndc11 (package): 00363780102
spl id: 0d82d9c4-814c-ed9b-e063-6294a90a6522
spl set id: 0681c6c5-5a8b-ea9e-e063-6394a90a83bc

Reported adverse events (FAERS/openFDA)#

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