FDA.reportPublic FDA data

Hot and Cold Cream with Lidocaine- RA

Manufacturer
Velocity Pharma LLC
Effective date
2020-10-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:31:32

Label at a glance#

ProductHot and Cold Cream with Lidocaine- RA Pain Relieving
Active ingredientLIDOCAINE, MENTHOL
Label structure8 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

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

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED 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

Uses

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
  • 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

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

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 ingredients

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.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hot and cold Cream -RA

Lidocaine

Plus Menthol

Pain Relieving Cream

Net Wt 2.7 OZ (76.5 g)

123123

11

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76168-309-302022-01-28C16284748780-1d6a99b39-4938-a426-e053-dadaa90af4c2Hot and Cold Pain Relieving Cream with Lidocaine- RA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-309-30Hot and Cold Cream with Lidocaine- RAPain Relieving76.5 g in 1 TUBECREAM76.54
76168-309-30Hot and Cold Cream with Lidocaine- RAPain Relieving1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-309HOT AND COLD CREAM WITH LIDOCAINE- RA PAIN RELIEVING (LIDOCAINE HCL AND MENTHOL) CREAM [VELOCITY PHARMA LLC]4Legacy NDC, 2 package rows20201014_ab927cf4-2302-4918-aef2-2bb309ee0181.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
76168-30976168-309-30

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-27H8VAM7778IACT
CETYL ALCOHOL936JST6JCNIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
LIGHT MINERAL OILN6K5787QVPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBIC ACIDX045WJ989BIACT
PETROLATUM4T6H12BN9UIACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB

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
b19030b2-4bc6-1689-e053-2995a90a05edab927cf4-2302-4918-aef2-2bb309ee01812020-10-13WarningsExact identifier
spl id: b19030b2-4bc6-1689-e053-2995a90a05ed
spl set id: ab927cf4-2302-4918-aef2-2bb309ee0181

Reported adverse events (FAERS/openFDA)#

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