FDA.reportPublic FDA data

Cool N' Heat Lidocaine Dry Spray

Manufacturer
TOPCO ASSOCIATES LLC
Effective date
2021-03-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:07

Label at a glance#

ProductCool N Heat Lidocaine Dry
Active ingredientLIDOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure9 sections

Dosage and administration

adults and children over 12 years : spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period product will dry quickly on its own, and does not need to be rubbed in children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurposes
Lidocaine 4%Topical anesthetic
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 label
  • do not allow contact with the eyes and mucous membranes
  • rare cases of serious burns have been reported with products of this type
  • do not apply to wounds or damaged, broken or irritated skin
  • avoid spraying on face
  • avoid inhalation of spray
  • do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
  • do not use at the same time as other topical analgesics
  • a transient burning sensation may occur upon application but generally disappears in several days
  • avoid applying into skin folds

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
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Extremely Flammable

SPL UNCLASSIFIED SECTION

  • do not use near heat or flame or while smoking
  • avoid long term storage above 104°F (40°C)
  • do not puncture or incinerate. Contents under pressure
  • do not store at temperatures above 120°F (49°C)

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years :

  • spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • product will dry quickly on its own, and does not need to be rubbed in

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

caprylic/capric triglyceride, isobutane, propylene glycol, SD alcohol 40B (30 %)

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 113 g Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 36800-908-35

TopCare
health®

COMPARE TO ICY HOT® LIDOCAINE PLUS
MENTHOL DRY SPRAY ACTIVE INGREDIENTS*

MAXIMUM STRENGTH

Cool n' Heat
Dry Spray
Pain Relief
with Lidocaine + Menthol

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

•OUR PHARMACISTS•
RECOMMEND

CONTINUOUS SPRAY

  • Temporarily Numbs
    Pain Away
  • Dries Instantly
  • Non-Greasy

✓QUALITY
GUARANTEED

NET WT 4 OZ (113 g)

Scan here for more
information or
call 1-888-423-0139

PRINCIPAL DISPLAY PANEL - 113 g Can Label
PRINCIPAL DISPLAY PANEL - 113 g Can Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595448lidocaine 4 % / menthol 1 % Topical SprayPSN2
1595448lidocaine 40 MG/ML / menthol 10 MG/ML Topical SpraySCD2
1595448lidocaine 4 % / menthol 1 % Topical SpraySY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-850-042023-01-30C16284748780-1f386c649-9aa1-0266-e053-dadaa90a7c1aCool N' Heat Lidocaine Dry Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-850-04Cool N Heat Lidocaine Dry113 g in 1 CANSPRAY1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-850COOL N HEAT LIDOCAINE DRY (LIDOCAINE AND MENTHOL, UNSPECIFIED FORM) SPRAY [TOPCO ASSOCIATES LLC]2Legacy NDC, 1 package rows20210501_a0df12b6-d721-48fc-9eca-49f5431df04e.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-85036800-850-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ISOBUTANEBXR49TP611IACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
e78e00d4-40d8-4ca6-9e06-0b8ee220c20da0df12b6-d721-48fc-9eca-49f5431df04e2021-03-08WarningsExact identifier
spl id: e78e00d4-40d8-4ca6-9e06-0b8ee220c20d
spl set id: a0df12b6-d721-48fc-9eca-49f5431df04e

Reported adverse events (FAERS/openFDA)#

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