Indications and uses
Temporarily relieves minor pain
Hot and Cold Cream with Lidocaine- RA
- Manufacturer
- Velocity Pharma LLC
- Effective date
- 2018-05-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:55:36
Label at a glance#
ProductHot and Cold Cream with Lidocaine- RA Pain Relieving
Active ingredientLIDOCAINE, MENTHOL
Label structure8 sections
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
HOT AND COLD CREAM with LIDOCAINE- RA
PAIN RELIEVING CREAM
Drug Facts
Active Ingredients
Lidocaine HCl 4%
Menthol 1%
Purposes
Lidocaine- Topical anesthetic,
Menthol- Topical Analgesic
Uses
Temporarily relieves minor pain
Warnings
For external use only
Do not use
- 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
- 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
- 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,
ask a health professional before use.
Keep out of reach of children and pets.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
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
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
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76168-204-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-237b-a910-e053-dadaa90a0b85 | Hot and Cold Pain Relieving Cream with Lidocaine- Careone |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76168-204-30 | Hot and Cold Cream with Lidocaine- RAPain Relieving | 76.5 g in 1 TUBE | CREAM | 76.5 | 2 | |
| 76168-204-30 | Hot and Cold Cream with Lidocaine- RAPain Relieving | 1 in 1 CARTON | CREAM | 1 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hot and Cold Cream with Lidocaine- RA Pain Relieving
- Lidocaine HCl and Menthol
- BUTYLATED HYDROXYTOLUENE
- CETOSTEARYL ALCOHOL
- CETETH-2
- CETYL ALCOHOL
- EDETATE DISODIUM
- SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
- LIGHT MINERAL OIL
- PROPYLENE GLYCOL
- SORBIC ACID
- PETROLATUM
- LIDOCAINE
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76168-204 | 76168-204-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| CETETH-2 | 7H8VAM7778 | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | 22ADO53M6F | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 6c800177-9889-61cb-e053-2991aa0adb1f | 74e7fba2-4054-4aae-9433-4dec382ca4d1 | 2018-05-18 | Warnings | 6c800177-9889-61cb-e053-2991aa0adb1f 74e7fba2-4054-4aae-9433-4dec382ca4d1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.