FDA.reportPublic FDA data

Maximum Strength Cold and Hot

Manufacturer
CVS | Product Quest Mfg
Effective date
2018-04-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:16

Label at a glance#

ProductMaximum Strength Cold and Hot CVS
Active ingredientLIDOCAINE HYDROCHLORIDE, Menthol
Label structure6 sections

Indications and uses

Temporarily relieves pain and itching due to: • sunburn • minor burns • minor cuts • scrapes • insect bites

Dosage and administration

• adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily • children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredients                            Purpose

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4%............................Topical analgesic

Menthol  1%.....................................Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to:
• sunburn • minor burns • minor cuts • scrapes • insect bites

WarningsFor external use only

WARNINGS SECTION

Do not use • in large quantities, particularly over raw surface or blistered areas

When using this product

OTC - WHEN USING SECTION

•avoid contact with eyes

• do not apply to wounds or damages skin
• do not bandage tightly or use with a heating pad
• use only as directed

OTC - STOP USE SECTION

Stop use and ask a doctor if 
• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily
• children under 12 years of age: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer
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 SE
Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer
Isohexadecane
Methylparaben
Polysorbate 60
SD Alcohol 40
Steareth-21
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
250912lidocaine 4 % / menthol 1 % Topical CreamPSN1
250912lidocaine 40 MG/ML / menthol 10 MG/ML Topical CreamSCD1
250912lidocaine 4 % / menthol 1 % 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-667-032020-01-31C16284748780-19d75b9d0-b67a-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-667-03Maximum Strength Cold and HotCVS80 mL in 1 BOTTLECREAM801
69842-667-03Maximum Strength Cold and HotCVS1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-667MAXIMUM STRENGTH COLD AND HOT CVS (LIDOCAINE HCI 4% MENTHOL 1%) CREAM [CVS]1Legacy NDC, 2 package rows20180426_7bad298f-59d7-4f9d-a122-54a02cb3f234.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-66769842-667-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MentholL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
Ceteth-20 Phosphate921FTA1500IACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
Dimethicone92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
Ethylhexylglycerin147D247K3PIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
Isohexadecane918X1OUF1EIACT
MethylparabenA2I8C7HI9TIACT
Polysorbate 60CAL22UVI4MIACT
ALCOHOL3K9958V90MIACT
Steareth-2153J3F32P58IACT
Water059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
92515a41-bdc9-4ec0-a720-ada9892b2ab37bad298f-59d7-4f9d-a122-54a02cb3f2342018-04-26WarningsExact identifier
spl id: 92515a41-bdc9-4ec0-a720-ada9892b2ab3
spl set id: 7bad298f-59d7-4f9d-a122-54a02cb3f234

Reported adverse events (FAERS/openFDA)#

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