Hot and Cold Cream with Lidocaine-RA

Manufacturer
Yash Pharmaceuticals | VELOCITY PHARMA
Effective date
2017-05-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:49:56

Label at a glance#

ProductHot and Cold with Lidocaine-RA Pain Relieving
Active ingredientLIDOCAINE, MENTHOL
Label structure3 sections

Label contents#

Full prescribing information#

Drug Facts

WARNINGS AND PRECAUTIONS SECTION

HOT AND COLD CREAM with LIDOCAINE-RA
PAIN RELIEVING CREAM
Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%
Menthol 1%

Purposes

OTC - PURPOSE SECTION

Lidocaine- Topical anesthetic,
Menthol- Topical Analgesic

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 SECTION

OTC - WHEN USING SECTION

  • Use only as directed. Read and follow all directions and warnings on this label
  • rare cases of serious burns have been reported with products of this type
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use or 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
If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

 KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION 

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children 12 years or younger: ask a doctor

INACTIVE INGREDIENT SECTION

Butylated hydroxyl toluene,cetostearyl alcohol,cetomacrogol 1000,cetyl alcohol,disodium EDTA,disodium hydrogen phosphate,light liquid paraffin,propylene glycol,sorbic acid,transquitol P, white petroleum jelly
Keep Carton As It Contains Important Information
Close cap tightly between uses.

Outer Label

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

Outer Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130011822686136GTIN-13: 0011822686136
EAN-13: 0011822686136
GTIN-12: 011822686136
UPC-A: 011822686136
GTIN storage (14 digits): 00011822686136
IMG_3988.jpg

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
71301-003-242020-01-31C16284748780-19d75b9d0-56bc-f424-e053-dadaa90a57ceHot and Cold Cream with Lidocaine-RA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71301-003-24Hot and Cold with Lidocaine-RAPain Relieving76.5 g in 1 BOTTLECREAM76.52
71301-003-24Hot and Cold with Lidocaine-RAPain Relieving192 in 1 CASECREAM1922

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71301-003HOT AND COLD WITH LIDOCAINE-RA PAIN RELIEVING (LIDOCAINE HCL AND MENTHOL) CREAM [YASH PHARMACEUTICALS]2Legacy NDC, 2 package rows20170525_1b502467-1bc8-4067-83e6-eb80d27651ee.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71301-00371301-003-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
505b4f4f-ba6e-339d-e054-00144ff88e881b502467-1bc8-4067-83e6-eb80d27651ee2017-05-25WarningsExact identifier
spl id: 505b4f4f-ba6e-339d-e054-00144ff88e88
spl set id: 1b502467-1bc8-4067-83e6-eb80d27651ee

Reported adverse events (FAERS/openFDA)#

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