Hot and Cold Cream with Lidocaine- CareOne

Manufacturer
SOTAC PHARMACEUTICALS PRIVATE LIMITED
Effective date
2018-05-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:43

Label at a glance#

ProductHot and Cold with Lidocaine-Careone 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

careone lm creamecareone lm creame

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-130041520112644GTIN-13: 0041520112644
EAN-13: 0041520112644
GTIN-12: 041520112644
UPC-A: 041520112644
GTIN storage (14 digits): 00041520112644
careone lm creame.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
72351-005-002021-01-29C16284748780-1ba0f9c33-5609-a910-e053-dadaa90a0b85Hot and Cold Cream with Lidocaine- CareOne

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72351-005-00Hot and Cold with Lidocaine-CareonePain Relieving128 in 1 CASECREAM1282
72351-005-00Hot and Cold with Lidocaine-CareonePain Relieving76.5 g in 1 BOTTLECREAM76.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72351-005HOT AND COLD WITH LIDOCAINE-CAREONE PAIN RELIEVING (LIDOCAINE HCL AND MENTHOL) CREAM [SOTAC PHARMACEUTICALS PRIVATE LIMITED]2Legacy NDC, 2 package rows20180531_a0c9a4bc-857b-405a-88f7-7df75e9d6385.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
72351-00572351-005-00

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
6d81faf7-aa2b-429c-e053-2a91aa0a8bb2a0c9a4bc-857b-405a-88f7-7df75e9d63852018-05-31WarningsExact identifier
spl id: 6d81faf7-aa2b-429c-e053-2a91aa0a8bb2
spl set id: a0c9a4bc-857b-405a-88f7-7df75e9d6385

Reported adverse events (FAERS/openFDA)#

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